Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609620071588 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined Hydroxyurea-Losartan Therapy for Early Sickle Cell Nephropathy in Children: A Multicenter Randomized Trial in Sub-Saharan Africa
Official scientific title “Combination Hydroxyurea-Losartan Therapy for Early Sickle Cell Nephropathy in Children: A Multicenter Randomized Trial in Sub-Saharan Africa”
Brief summary describing the background and objectives of the trial Sickle cell nephropathy is a leading cause of chronic kidney disease in children with sickle cell disease (SCD). Glomerular hyperfiltration and albuminuria are early manifestations associated with progressive renal impairment. Hydroxyurea improves several renal outcomes, but data on the additional benefit of losartan in children remain limited. We evaluated whether adding losartan to hydroxyurea improves renal outcomes compared with hydroxyurea alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Kidney Disease,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 26/04/2023
Actual Last follow-up date 26/04/2023
Anticipated target sample size (number of participants) 94
Actual target sample size (number of participants) 94
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hydroxyurea and Losartan Hydroxyurea: 15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day. Losartan: 0.7 mg/kg/day initially, increased by 0.3 mg/kg every 3 months up to a maximum of 1.4 mg/kg/day, if tolerated. 9 months Hydroxyurea was initiated at 15 mg/kg/day and increased by 2.5 mg/kg/day after 3 months according to tolerance and hematological parameters. Losartan was administered at a dose of up to 1.4 mg/kg/day. The combination treatment was continued throughout the 9-month follow-up period. Participants were monitored regularly for clinical, renal, hematological, and treatment-related outcomes. 48
Control Group Hydroxyurea alone Hydroxyurea : 15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day.15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day. 9 months Hydroxyurea was initiated at 15 mg/kg/day and increased by 2.5 mg/kg/day after 3 months according to tolerance and hematological parameters. Hydroxyurea alone was continued throughout the 9-month follow-up period. Participants were monitored regularly for clinical, renal, hematological, and treatment-related outcomes. 46 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Enfants atteints de drépanocytose présentant une insuffisance rénale précoce selon les critères rénaux définis par l’étude. Les enfants âgés de 6 à 18 ans présentant une SCD confirmée Les enfants présentant des anomalies rénales précoces étaient éligibles. Children with: age outside the 6–18-year range; treatment with hydroxyurea (HU), angiotensin receptor blockers (ARBs), or angiotensin-converting enzyme (ACE) inhibitors within the two weeks preceding enrollment; estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²; gross hematuria, nitrituria, or leukocyturia; hyperkalemia (K ≥5.5 mEq/L); or refusal to participate. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 6 Year(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2022 National Ethics Committee of Health
Ethics Committee Address
Street address City Postal code Country
Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality Kinshasa 1024 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants (%) achieving a ≥50% reduction in at least one early renal marker. Reduction in the prevalence of early renal impairment markers, including albuminuria and glomerular hyperfiltration, following treatment with hydroxyurea plus losartan compared with hydroxyurea alone. M0:Baseline assessment, performed before initiation of treatment. M3:Assessment after 3 months of treatment. M6: Assessment after 6 months of treatment. M9:Assessment after 9 months
Secondary Outcome Changes in clinical and laboratory parameters during follow-up. M0:Baseline assessment, performed before initiation of treatment. M3:Assessment after 3 months of treatment. M6: Assessment after 6 months of treatment. M9:Assessment after 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Biamba Marie Mutombo Hospital 9777 Boulevard Lumumba, Masina municipality Kinshasa 1022 Democratic Republic of the Congo
University Clinics of Kinshasa Road Kimwenza, Lemba municipality Kinshasa 123 Democratic Republic of the Congo
Center for Mixed Medicine and SS Anemia No. 9, Place Mange, Yolo-Sud District, Kalamu Municipality, Kinshasa 1213 Democratic Republic of the Congo
Diamant Medical Center. 3642 Boulevard du 30 Juin, Futur Tower, Gombe Municipality Kinshasa 1204 Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Lomo Medical Center 1307, Avenue de la Poste, Limete Municipality, Kinshasa 12345 Democratic Republic of the Congo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Betukumesu Kabesele Dieu merci 46B, 4th Debonhome Street, Debonhome District, Matete Municipality Kinshasa 170 Democratic Republic of the Congo Individual
Secondary Sponsor Longo Mbenza Benjamin 1307, Avenue de la Poste, Limete Municipality, Kinshasa 12345 Democratic Republic of the Congo Hospital
COLLABORATORS
Name Street address City Postal code Country
Arriel Makembi Saint Laurent du Maroni, 97320 Saint Laurent du Maroni 97320 French Guiana
Mireille Nganga street Biangala 4/B, Lemba municipallity Kinshasa 123 Democratic Republic of the Congo
Jonathan Mutudiwu Street TP 18, Limete Municipallity Kinshasa 127 Democratic Republic of the Congo
Michel Aloni Maison L9, Plateau of residents, Lemba municipality Kinshasa 123 Democratic Republic of the Congo
Paul Lumbala 46, street Lutondo, Ngaliema Municipality Kinshasa 123 Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dieu merci Betukumesu Kabasele dieumercibetu@gmail.com +243826976624 46B, 4th Debonhome Street, Debonhome District, Matete Municipality, Kinshasa, Democratic Republic of the Congo
City Postal code Country Position/Affiliation
Kinshasa 170 Democratic Republic of the Congo University of Kinshasa
Role Name Email Phone Street address
Public Enquiries Mireiile Nganga mireille.nganga@unikin.ac.cd +243812667347 Street Biangala 3/B, Lemba municipallity
City Postal code Country Position/Affiliation
Kinshasa 123 Democratic Republic of the Congo University of Kinshasa
Role Name Email Phone Street address
Scientific Enquiries Arriel Makembi docteur.makarriel2017@gmail.com +33754244277 Saint Laurent du Maroni, 97320, French Guiana,
City Postal code Country Position/Affiliation
Saint Laurent du Maroni 97320 French Guiana University hospital of French Guiana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will include sociodemographic and clinical characteristics, treatment allocation, hematological and biochemical parameters, renal parameters including estimated glomerular filtration rate and urinary albumin-to-creatinine ratio, inflammatory markers, treatment adherence, and adverse events collected at baseline and during follow-up at 15 days, 3, 6, and 9 months. Informed Consent Form,Statistical Analysis Plan,Study Protocol No IPD sharing Qualified researchers may request access to individual participant data upon reasonable request. Access will be subject to approval by the study investigators, ethical requirements, and applicable data protection regulations.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/08/2026 Result - 28/08/2026 Result - 28/08/2026 Result - 28/08/2026 Result - 28/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 28/08/2026 Lack of information “Hydroxyurea-Losartan Therapy for Early Sickle Cell Nephropathy in Children: A Multicenter Randomized Trial in Sub-Saharan Africa” Combined Hydroxyurea-Losartan Therapy for Early Sickle Cell Nephropathy in Children: A Multicenter Randomized Trial in Sub-Saharan Africa
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 28/08/2026 Insufficient information Phase-1 Phase-3
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 28/08/2026 Addition of information 48 94
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 28/08/2026 Addition of information Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 28/08/2026 Insufficient information Children aged 6-18 years with confirmed SCD and early renal abnormalities were eligible. Les enfants âgés de 6 à 18 ans présentant une SCD confirmée Children with early renal abnormalities were eligible.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 28/08/2026 Insufficient information Les enfants âgés de 6 à 18 ans présentant une SCD confirmée Children with early renal abnormalities were eligible. Children with sickle cell disease presenting early renal impairment according to the study-defined renal criteria. Les enfants âgés de 6 à 18 ans présentant une SCD confirmée Les enfants présentant des anomalies rénales précoces étaient éligibles.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 28/08/2026 Addition of information Children with sickle cell disease presenting early renal impairment according to the study-defined renal criteria. Les enfants âgés de 6 à 18 ans présentant une SCD confirmée Les enfants présentant des anomalies rénales précoces étaient éligibles. Enfants atteints de drépanocytose présentant une insuffisance rénale précoce selon les critères rénaux définis par l’étude. Les enfants âgés de 6 à 18 ans présentant une SCD confirmée Les enfants présentant des anomalies rénales précoces étaient éligibles.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 28/08/2026 Insufficient information Age outside the 6-18-year range; treatment with HU, ARBs, or ACE inhibitors within 2 weeks before enrollment; eGFR <60 mL/min/1.73 m²; gross hematuria, nitrituria, or leukocyturia; hyperkalemia (K ≥5.5 mEq/L); or refusal to participate. Âge en dehors de la fourchette 6-18 ans ; traitement par HU, ARB ou inhibiteurs de l’ECA dans les deux semaines précédant l’inscription ; eGFR <60 mL/min/1,73 m² ; l’hématurie macroscopique, la nitriturie ou la leucocyturie ; hyperkaliémie (K ≥5,5 mEq/L) ; ou refus de participer.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 28/08/2026 Addition of information Âge en dehors de la fourchette 6-18 ans ; traitement par HU, ARB ou inhibiteurs de l’ECA dans les deux semaines précédant l’inscription ; eGFR <60 mL/min/1,73 m² ; l’hématurie macroscopique, la nitriturie ou la leucocyturie ; hyperkaliémie (K ≥5,5 mEq/L) ; ou refus de participer. Children with: age outside the 6–18-year range; treatment with hydroxyurea (HU), angiotensin receptor blockers (ARBs), or angiotensin-converting enzyme (ACE) inhibitors within the two weeks preceding enrollment; estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²; gross hematuria, nitrituria, or leukocyturia; hyperkalemia (K ≥5.5 mEq/L); or refusal to participate.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/08/2026 Addition of information Experimental Group, Hydroxyurea and Losartan, Hydroxyurea: 15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day. Losartan: 0.7 mg/kg/day initially, increased by 0.3 mg/kg every 3 months up to a maximum of 1.4 mg/kg/day, if tolerated., 9 months, Hydroxyurea was initiated at 15 mg/kg/day and increased after 3 months by 2.5 mg/kg/day according to tolerance, defined by the absence of hematological toxicity (neutrophils ≥2,000/mm³ and platelets ≥80,000/mm³). The average hydroxyurea dose was approximately 20 mg/kg/day. Losartan was started at 0.7 mg/kg/day and increased by 0.3 mg/kg every 3 months, up to 1.4 mg/kg/day, if tolerated., 48, Experimental Group, Hydroxyurea and Losartan, Hydroxyurea: 15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day. Losartan: 0.7 mg/kg/day initially, increased by 0.3 mg/kg every 3 months up to a maximum of 1.4 mg/kg/day, if tolerated., 9 months, Hydroxyurea was initiated at 15 mg/kg/day and increased by 2.5 mg/kg/day after 3 months according to tolerance and hematological parameters. Losartan was administered at a dose of up to 1.4 mg/kg/day. The combination treatment was continued throughout the 9-month follow-up period. Participants were monitored regularly for clinical, renal, hematological, and treatment-related outcomes., 48,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/08/2026 Addition of information Control Group, Hydroxyurea alone, Hydroxyurea : 15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day.15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day., 9 months, Hydroxyurea was initiated at 15 mg/kg/day and increased after 3 months by 2.5 mg/kg/day according to tolerance, defined by the absence of hematological toxicity (neutrophils ≥2,000/mm³ and platelets ≥80,000/mm³). The average hydroxyurea dose was approximately 20 mg/kg/day. Participants in the control group did not receive losartan., 46, Active-Treatment of Control Group Control Group, Hydroxyurea alone, Hydroxyurea : 15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day.15 mg/kg/day initially, increased by 2.5 mg/kg/day after 3 months according to tolerance; average dose approximately 20 mg/kg/day., 9 months, Hydroxyurea was initiated at 15 mg/kg/day and increased by 2.5 mg/kg/day after 3 months according to tolerance and hematological parameters. Hydroxyurea alone was continued throughout the 9-month follow-up period. Participants were monitored regularly for clinical, renal, hematological, and treatment-related outcomes., 46, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 28/08/2026 Addition of information Primary Outcome, Reduction in the prevalence of early renal impairment markers, including albuminuria and glomerular hyperfiltration, following treatment with hydroxyurea plus losartan compared with hydroxyurea alone., 0,3,6,9 months Primary Outcome, Proportion of participants (%) achieving a ≥50% reduction in at least one early renal marker. Reduction in the prevalence of early renal impairment markers, including albuminuria and glomerular hyperfiltration, following treatment with hydroxyurea plus losartan compared with hydroxyurea alone., M0:Baseline assessment, performed before initiation of treatment. M3:Assessment after 3 months of treatment. M6: Assessment after 6 months of treatment. M9:Assessment after 9 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 28/08/2026 Addition of information Secondary Outcome, Changes in clinical and laboratory parameters during follow-up., 0,3,6,9 months Secondary Outcome, Changes in clinical and laboratory parameters during follow-up., M0:Baseline assessment, performed before initiation of treatment. M3:Assessment after 3 months of treatment. M6: Assessment after 6 months of treatment. M9:Assessment after 9 months
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 28/08/2026 Addition of information University Clinics of Kinshasa, Road Kimwenza, Lemba,, Kinshasa, 0127, Democratic Republic of the Congo University Clinics of Kinshasa, Road Kimwenza, Lemba municipality, Kinshasa, 123, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 28/08/2026 Addition of information Biamba Marie Mutombo Hospital, 9777 Boulevard Lumumba, Commune de Masina City, Kinshasa, 0127, Democratic Republic of the Congo Biamba Marie Mutombo Hospital, 9777 Boulevard Lumumba, Commune de Masina City, Kinshasa, 1022, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 28/08/2026 Addition of information Biamba Marie Mutombo Hospital, 9777 Boulevard Lumumba, Commune de Masina City, Kinshasa, 1022, Democratic Republic of the Congo Biamba Marie Mutombo Hospital, 9777 Boulevard Lumumba, Masina municipality, Kinshasa, 1022, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 28/08/2026 Addition of information Center for Mixed Medicine and SS Anemia, No. 9, Place Mange, Yolo-Sud District, Kalamu Municipality, , Kinshasa, 0127, Democratic Republic of the Congo Center for Mixed Medicine and SS Anemia, No. 9, Place Mange, Yolo-Sud District, Kalamu Municipality, , Kinshasa, 1213, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 28/08/2026 Addition of information Diamant Medical Center., 3642 Boulevard du 30 Juin, Futur Tower, Gombe Municipality, Kinshasa, 0127, Democratic Republic of the Congo Diamant Medical Center., 3642 Boulevard du 30 Juin, Futur Tower, Gombe Municipality, Kinshasa, 1204, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/08/2026 Lack of information TRUE, National Ethics Committee of Health, Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality, Kinshasa, 0127, Democratic Republic of the Congo, , 19 Sep 2022, +243998419816, feli1munday@yahoo.fr, 44915_40265_4737.pdf TRUE, National Ethics Committee of Health, Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality, Kinshasa, 0127, Democratic Republic of the Congo, , 19 Sep 2022, +243998419816, feli1munday@yahoo.fr, 44915_40265_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/08/2026 Lack of information TRUE, National Ethics Committee of Health, Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality, Kinshasa, 0127, Democratic Republic of the Congo, , 19 Sep 2022, +243998419816, feli1munday@yahoo.fr, 44915_40265_4737.pdf TRUE, National Ethics Committee of Health, Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality, Kinshasa, 0127, Democratic Republic of the Congo, , 19 Sep 2022, +243998419816, feli1munday@yahoo.fr, 44915_40265_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/08/2026 Addition of information TRUE, National Ethics Committee of Health, Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality, Kinshasa, 0127, Democratic Republic of the Congo, , 19 Sep 2022, +243998419816, feli1munday@yahoo.fr, 44915_40265_4737.pdf TRUE, National Ethics Committee of Health, Immeuble PNMLS, 1st Floor, Local 5, Kasa-Vubu Municipality, Kinshasa, 1024, Democratic Republic of the Congo, , 19 Sep 2022, +243998419816, feli1munday@yahoo.fr, 44915_40265_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 28/08/2026 Addition of information Lomo medical, 1307, Avenue de la Poste, Limete Municipality,, Kinshasa, 0127, Democratic Republic of the Congo, Hospital, Lomo University, 1307, Avenue de la Poste, Limete Municipality,, Kinshasa, 131, Democratic Republic of the Congo, University,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 28/08/2026 Addition of information Lomo University, 1307, Avenue de la Poste, Limete Municipality,, Kinshasa, 131, Democratic Republic of the Congo, University, Lomo Medical Center, 1307, Avenue de la Poste, Limete Municipality,, Kinshasa, 12345, Democratic Republic of the Congo, Hospital,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 28/08/2026 Addition of information Betukumesu Kabesele Dieu merci, 46B, 4th Debonhome Street, Debonhome District, Matete Municipality, Kinshasa, 0127, Democratic Republic of the Congo, Primary Sponsor, Individual, Betukumesu Kabesele Dieu merci, 46B, 4th Debonhome Street, Debonhome District, Matete Municipality, Kinshasa, 170, Democratic Republic of the Congo, Primary Sponsor, Individual,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 28/08/2026 Addition of information Longo Mbenza Benjamin, 1307, Avenue de la Poste, Limete Municipality,, Kinshasa, 0127, Democratic Republic of the Congo, Secondary Sponsor, Hospital, Longo Mbenza Benjamin, 1307, Avenue de la Poste, Limete Municipality,, Kinshasa, 12345, Democratic Republic of the Congo, Secondary Sponsor, Hospital,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 28/08/2026 Addition of information Mireille Nganga, street Biangala 4/B, Lemba municipallity, Kinshasa, 0127, Democratic Republic of the Congo Mireille Nganga, street Biangala 4/B, Lemba municipallity, Kinshasa, 123, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 28/08/2026 Addition of information Jonathan Mutudiwu, Street TP 18, Limete Municipallity, Kinshasa, 0127, Democratic Republic of the Congo Jonathan Mutudiwu, Street TP 18, Limete Municipallity, Kinshasa, 127, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 28/08/2026 Addition of information Michel Aloni, Maison L9, Plateau of residents, Lemba municipality, Kinshasa, 0127, Democratic Republic of the Congo Michel Aloni, Maison L9, Plateau of residents, Lemba municipality, Kinshasa, 123Additi, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 28/08/2026 Addition of information Michel Aloni, Maison L9, Plateau of residents, Lemba municipality, Kinshasa, 123Additi, Democratic Republic of the Congo Michel Aloni, Maison L9, Plateau of residents, Lemba municipality, Kinshasa, 123, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 28/08/2026 Addition of information Paul Lumbala, 46, street Lutondo, Ngaliema Municipality , Kinshasa, 0127, Democratic Republic of the Congo Paul Lumbala, 46, street Lutondo, Ngaliema Municipality , Kinshasa, 123, Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 28/08/2026 Addition of information Principal Investigator, Dieu merci, Betukumesu Kabasele, Dr., dieumercibetu@gmail.com, dieumerci.betukumesu@unikin.ac.cd, +243826976624, 46B, 4th Debonhome Street, Debonhome District, Matete Municipality, Kinshasa, Democratic Republic of the Congo, Kinshasa, 0127, Democratic Republic of the Congo, University of Kinshasa Principal Investigator, Dieu merci, Betukumesu Kabasele, Dr., dieumercibetu@gmail.com, dieumerci.betukumesu@unikin.ac.cd, +243826976624, 46B, 4th Debonhome Street, Debonhome District, Matete Municipality, Kinshasa, Democratic Republic of the Congo, Kinshasa, 170, Democratic Republic of the Congo, University of Kinshasa
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 28/08/2026 Addition of information Public Enquiries, Mireiile, Nganga, Prof., mireille.nganga@unikin.ac.cd, , +243812667347, Street Biangala 3/B, Lemba municipallity, Kinshasa, 0127, Democratic Republic of the Congo, University of Kinshasa Public Enquiries, Mireiile, Nganga, Prof., mireille.nganga@unikin.ac.cd, , +243812667347, Street Biangala 3/B, Lemba municipallity, Kinshasa, 123, Democratic Republic of the Congo, University of Kinshasa
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 28/08/2026 Addition of information Scientific Enquiries, Arriel , Makembi, Dr., docteur.makarriel2017@gmail.com, , +33754244277, Saint Laurent du Maroni, 97320, French Guiana,, Saint Laurent du Maroni, 97320, France, University hospital of French Guiana Scientific Enquiries, Arriel , Makembi, Dr., docteur.makarriel2017@gmail.com, , +33754244277, Saint Laurent du Maroni, 97320, French Guiana,, Saint Laurent du Maroni, 97320, French Guiana, University hospital of French Guiana
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 28/08/2026 Addition of information Access will not be granted to individual participant data. Only aggregated, anonymized results will be shared. Qualified researchers may request access to individual participant data upon reasonable request. Access will be subject to approval by the study investigators, ethical requirements, and applicable data protection regulations.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 28/08/2026 Addition of information 44915_31039_1045.pdf 44915_31039_1045.pdf
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Reporting Result Summary Pdf file1 28/08/2026 Addition of information 44915_31039_1045.pdf 44915_31039_1045.pdf
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Reporting Result Summary Pdf file1 28/08/2026 Addition of information 44915_31039_1045.pdf 44915_31039_1045.pdf
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Reporting Result Summary Pdf file 2 28/08/2026 Addition of information 44915_31039_1046.pdf 44915_31039_1046.pdf
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Reporting Result Summary Pdf file 2 28/08/2026 Addition of information 44915_31039_1046.pdf 44915_31039_1046.pdf
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Reporting Result Summary Pdf file 2 28/08/2026 Addition of information 44915_31039_1046.pdf 44915_31039_1046.pdf
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Reporting Result Summary Pdf file 3 28/08/2026 Addition of information 44915_31039_1047.pdf 44915_31039_1047.pdf
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Reporting Result Summary Pdf file 3 28/08/2026 Addition of information 44915_31039_1047.pdf 44915_31039_1047.pdf
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Reporting Result Summary Pdf file 3 28/08/2026 Addition of information 44915_31039_1047.pdf 44915_31039_1047.pdf
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Reporting Result Summary Pdf file 4 28/08/2026 Addition of information 44915_31039_1048.pdf 44915_31039_1048.pdf
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Reporting Result Summary Pdf file 4 28/08/2026 Addition of information 44915_31039_1048.pdf 44915_31039_1048.pdf
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Reporting Result Summary Pdf file 4 28/08/2026 Addition of information 44915_31039_1048.pdf 44915_31039_1048.pdf
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Reporting Result Summary Pdf file 5 28/08/2026 Addition of information 44915_31039_1049.pdf 44915_31039_1049.pdf
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Reporting Result Summary Pdf file 5 28/08/2026 Addition of information 44915_31039_1049.pdf 44915_31039_1049.pdf
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Reporting Result Summary Pdf file 5 28/08/2026 Addition of information 44915_31039_1049.pdf 44915_31039_1049.pdf