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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202211560561994 Date of Approval: 21/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Study of Apoptosis in Lupus Nephritis patients to assess glomerular and tubular damage.
Official scientific title A Study of Apoptosis in Lupus Nephritis patients through a study of Bcl-2 vs PDL-1 to assess glomerular and tubular damage.
Brief summary describing the background and objectives of the trial In lupus glomerulonephritis, apoptotic cell death affects mesangial cells, glomerular-tuft endothelial cells, leucocytes, and macrophages. Two important molecules are involved in this process: Bcl-2 and PDL-1, which promote cell survival and death, respectively. What does this study add? Theory We hypothesized that the expression of apoptotic proteins of the intrinsic pathway might have a role in the pathogenesis of lupus nephritis and thus it might be related to the class of the disease and its activity. In our study, we focused on the ratio between the immunohistochemical expression of PDL1 and bcl2 proteins and the correlation between the PDL1 to bcl2 ratio and the active and chronic glomerular lesions in human LN.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Lupus Nephritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/11/2022
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL not applicable
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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 lupus nephritis group once time from each patient - The classification of lupus nephritis, including biopsy A/C index, will be performed following World Health Organization (WHO) classification . Renal function tests (blood urea and creatinine levels, creatinine clearance). - Immunohistochemically evaluation of Bcl-2 and PLD-1 expression in renal tissue (glomerular and tubular tissue) 30
Control Group control group not applicable not applicable BCL2 and PDL1 will be detected from normal tissue adjacent to tissue that had been removed from other causes ( Five formalin-fixed paraffin blocks of morphologically normal renal tissue will be obtained from normal renal tissue adjacent to renal neoplasms in nephrectomy specimens as a control group.) 5 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with lupus nephritis who have done renal biopsies age: more than 18 years old patients with lupus nephritis who did not have renal biopsies age : less than 12 yaers patients with history of malignancy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 05/09/2022 FMASU
Ethics Committee Address
Street address City Postal code Country
56 Ramsis St., Abbasseya, Cairo cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lupus nephritis is associated with alterations of tubular and glomerular Bcl-2 2 months
Secondary Outcome evaluation PLD-1 expression in renal tissue (glomerular and tubular tissue) 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university 56 Ramsis St., Abbasseya, Cairo Cairo 11655 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle investigator 56 Ramsis St., Abbasseya, Cairo cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hossam salah 56 Ramsis St., Abbasseya, Cairo Cairo 11566 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam Labib hossam_salah@med.asu.edu.eg +21002058687 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Shereen Fawaz dr.sam789@yahoo.com +21001242964 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Manal Salman dr.sam789@yahoo.com +21006049309 56 Ramsis St., Abbasseya
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data sets to be used and/or analyzed during the current study will be available after the study's completion from the corresponding author by e-mail upon reasonable request from researchers who make a sound methodological suggestion. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date individual participant data (including data dictionaries) will be shared, what data, in particular, will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable 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