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.: PACTR202511791015107 Date of Registration: 19/11/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Incidence of infection associated with the proactive intravenous iron therapy in patients with chronic kidney disease
Official scientific title Incidence of infection associated with the proactive intravenous iron therapy in patients with chronic kidney disease
Brief summary describing the background and objectives of the trial Iron is an essential micronutrient required for vital physiological processes in both humans and pathogens. Its role in cellular respiration, DNA synthesis, and immune regulation underscores its importance in maintaining health. However, this indispensable element also becomes a double-edged sword in the context of infection. Pathogens, much like host cells, rely on iron for survival and replication, creating a biological battleground for its acquisition The clinical implications of these findings are particularly significant in chronic kidney disease (CKD) patients, who frequently suffer from anemia and are treated with intravenous (IV) iron therapy. IV iron bypasses natural iron-regulating mechanisms and can transiently increase free iron in the circulation, potentially promoting infection in a population already immunocompromised due to uremia and frequent vascular access interventions The potential risks of IV iron therapy in this population, especially among high responders (those who achieve rapid or significant increases in hemoglobin or ferritin), remain under active investigations the aim of the study To evaluate the risk of infection (respiratory, UTI infection or others ) with proactive high dose IV iron within chronic kidney disease patients.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2025
Actual trial start date
Anticipated date of last follow up 01/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Single Group Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravenous iron therapy 400 mg per month 3 months Administration of intravenous (IV) iron therapy (400 mg per month) until patients achieved targeted hemoglobin level (10-11 g/L) or serum ferritin >700 mg/L or a transferrin saturation [TSAT] >40% (per month). 300
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Adult patients (≥19 years old). 2. Diagnosed with chronic kidney disease (CKD) stages 3 to 5 (pre-dialysis). 3. Documented iron dficiency anemia, defined as: Serum ferritin <100 ng/mL or Transferrin saturation (TSAT) <20%. 1.Presence of active infection at the time of IV iron administration (e.g., fever, elevated CRP/WBCs, clinically diagnosed infection) 2. History of recent hospitalization due to infection within the past 4 weeks. 3. Patients currently on or recently received antibiotics within 2 weeks prior to enrollment. 4. Known hypersensitivity or adverse reaction to IV iron preparations. 5. Severe liver disease or active hepatitis. 6. Patients with iron overload, defined as: Serum ferritin >800 ng/mL or TSAT >50% at baseline. 7. Malignancy or ongoing chemotherapy/immunosuppressive therapy. 8. Pregnant or breastfeeding women. 9. Non-compliant patients or those with incomplete medical records that prevent accurate follow-up. Informed Consent will be obtained from all participants. The approval of ethical committee as well 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 85 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
No 24/11/2025 Institutional Review Board of Faculty of Medicine Assiut university
Ethics Committee Address
Street address City Postal code Country
Assiut university Asyut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of infection in CKD patients receiving intravenous iron therapy 3 months postintervention
Secondary Outcome Time to first infection episode after IV iron therapy. 3 months postintervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university hospital Assiut university Asyut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa mohamed Assiut university Asyut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alaa mohamed Assiut university Asyut 71515 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Alaa mohamed mahmoud saleh Alaa.17289709@med.aun.edu.eg 01016631697 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt residant doctor at Internal medicine departement
Role Name Email Phone Street address
Scientific Enquiries Omnia Hashem Omniahashem67@aun.edu.eg +201019913001 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt professor of internal medicine
Role Name Email Phone Street address
Principal Investigator Howaida abd elhakeem nafady howaidanafady3@gmail.com 201094721339 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt professor of internal medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes Study Protocol 12 month post publication of results data will be available upon a reasonable request from the corresponding author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information