IgA nephropathy study in Indians

Not Applicable

Completed

• Conditions: Chronic kidney disease and IgA nephropathy (IgAN); Urological and Genital Diseases; Chronic kidney disease

• Registration Number: ISRCTN36834159
• Lead Sponsor: Christian Medical College

Brief Summary

2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30345379/ (added 21/11/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33615067/ Baseline clinical, biochemical, and histopathologic characteristics (added 21/11/2023) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/35155869/ Three-year clinical outcomes (added 21/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-11
• Study Completion: 2021-12-31
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Levels of serum Gd-IgA1 and AGlyIgA including immune complexes, measured using ELISA at baseline and annually<br> 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)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Co-deposition of components of the lectin and alternative pathway of complement activation in renal biopsies, measured by immunofluorescence and immunohistochemistry at baseline<br> 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)<br>