IgA nephropathy study in Indians

• Register: ISRCTN
• Last refreshed on: 4 December 2023
• Main ID: ISRCTN36834159
• Date of registration: 11/10/2017
• Prospective Registration: No
• Primary sponsor: Christian Medical College
• Public title: IgA nephropathy study in Indians
• Scientific title: Why is IgA nephropathy aggressive in Indians? Study of the effect of galactose deficient IgA1, anti-glycan antibodies including immune complexes and complement components on the rate of progression of renal disease.
• Date of first enrolment: 09/03/2015
• Target sample size: 500
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN36834159
• Study type: Observational
• Study design: Observational prospective longitudinal cohort study (Other)
• Phase: Not Applicable

Countries of recruitment

India

Contacts

• Name: Suceena Alexander

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age =18 years
2. Primary IgA nephropathy diagnosed by renal biopsy
3. Written informed consent
4. Willing to come for follow-up visits
5. Immunosuppression naive for three months prior to recruitment

Exclusion criteria:
1. Secondary IgA nephropathy: e.g. due to lupus, liver cirrhosis, Henoch-Schonlein purpura
2. Glomerular filtration rate (GFR) as estimated by the CKD-EPI equation <10ml/min/1.73m2
3. Participants with systemic diseases that can affect the kidneys like diabetes, systemic lupus erythematosus, presence of HIV, HbsAg, HCV infections, malignancies etc
4. Participants with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic kidney disease and IgA nephropathy (IgAN)
Urological and Genital Diseases
Chronic kidney disease

Intervention(s)

200 IgAN patients will be recruited and classified into low and high risk groups based on a validated risk score. High risk IgAN group are IgAN patients with an Absolute Renal Risk (ARR) score of =23 points. Low risk IgAN group are IgAN patients with an ARR score of <23 points. Equivalent number of healthy people and patients with other glomerulonephritis will serve as controls for standardisation methods in sera. Based on the rate of decline in estimated glomerular filtration rate (eGFR) during the average five-year follow-up, the primary clinical outcome in IgAN patients will be either rapid-progressors or slow/non-progressors. Antigen, antibody and complement staining in renal tissue at baseline will be correlated with clinical outcomes at follow-up. Molecular characterization of biomarkers in sera collected annually will be compared between the two groups. The trialists hope to incorporate these biomarkers into a risk score equation for better determination of disease prognosis in our population. They will also be bio-banking biological fluids for future biomarker analysis.

Primary Outcome(s)

1. Levels of serum Gd-IgA1 and AGlyIgA including immune complexes, measured using ELISA at baseline and annually
2. Rate of progression of IgAN, measured by the rate of fall in estimated glomerular filtration rate (eGFR) estimated by the CKD-EPI creatinine equation measured annually till composite end-point or end of follow-up (average of five years)

Secondary Outcome(s)

1. Composite end-point of 50% decline in eGFR, ESKD or death, whichever occurs earlier, measured using CKD-EPI creatinine equation and ESKD defined as eGFR by CKD-EPI creatinine equation <15ml/min/1.73m2 and/or requiring renal replacement therapy
2. Co-deposition of components of the lectin and alternative pathway of complement activation in renal biopsies, measured by immunofluorescence and immunohistochemistry at baseline
3. Proteinuria, measured using 24 hour urine protein (g/day) at baseline and annually till composite end-point or end of follow-up (average of five years)

Secondary ID(s)

IA/CPHE/14/1/501501

Source(s) of Monetary Support

Christian Medical College, Vellore, DBT India Alliance

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. Pilot study: The Institutional Review Board (Silver, Research and Ethics Committee) of the Christian Medical College Vellore, 23/07/2014, Ref. No. IRB Min. No. 8962 2. Full study: The Institutional Review Board (Silver, Research and Ethics Committee) of the Christian Medical College Vellore, 24/06/2015, Ref. No. IRB Min. No. 9481

Results

• Results available: Yes
• Date Completed: 31/12/2021