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Study identifier: NCT06676384 Synced from ClinicalTrials.gov · July 28, 2026
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Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?

Condition: IgA Nephropathy · Renal Insufficiency, Chronic · IgA Vasculitis  ·  Sponsor: Christian Medical College, Vellore, India

PhasePhase 4
Planned participants585
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

Global Burden of Diseases ranks chronic kidney disease (CKD) as the 12th leading cause of death, with an estimated 20% increase from 2010 to 2019. India is the most populous country in South Asia, with one-fourth of the global population. CKD prevalence has reached epidemic proportions in South Asia, with 1 in 7 adults affected by it. Glomerular diseases are the most common cause of CKD after diabetes and hypertension. IgAN is the most common primary glomerular disease in adults. In the Caucasian and East Asian populations, IgAN results in end-stage kidney disease (ESKD) in 15-20% of patients within 15-20 years after the first clinical presentation. Our first prospective observational (GRACE-IgANI) cohort since 2015 showed that South Asians have severe and progressive IgAN, with 39% having a rapid fall in eGFR, 25% having non-remission of proteinuria, and 36% reaching an adverse kidney outcome at three years. Our group has shown that South Asian ethnicity is associated with a severe phenotype, rapid progression, and significant ethnic differences in biomarkers. Over the last few years, newer anti-proteinuric agents and immunomodulatory drugs have either been approved by the FDA or are in the late phases of clinical trials for various proteinuric kidney diseases. The results of the STOP-IgAN and the recent TESTING trial have shown that the short-term beneficial effects of steroids on proteinuria and eGFR slope at six months wane over time, and there is a need for effective l…

This description comes directly from the study's public registry record.

Talk to the study team

Suceena Alexander, DM, PhD.  ·  +91-417-  ·  suceena@cmcvellore.ac.in

Selvin Sundar Raj, MD, DM  ·  +91-417-  ·  selvinsr@cmcvellore.ac.in

Always discuss trial participation with your own doctor first.

Locations (12)

Muljibhai Patel Urological HospitalNadiād, Gujarat, IndiaNot Yet Recruiting
JSS Medical CollegeMysuru, Karnataka, IndiaNot Yet Recruiting
Kasturba Medical College, ManipalUdupi, Karnataka, IndiaNot Yet Recruiting
KEM HospitalMumbai, Maharashtra, IndiaNot Yet Recruiting
Safdarjung Hospital, Ansari Nagar EastDelhi, New Delhi, IndiaNot Yet Recruiting
AIIMS BhubaneswarBhubaneswar, Odisha, IndiaNot Yet Recruiting
JIPMER, JIPMER CampusPuducherry, Puducherry, IndiaNot Yet Recruiting
Madras Medical CollegeChennai, Tamil Nadu, IndiaNot Yet Recruiting
Christian Medical College VelloreVellore, Tamil Nadu, IndiaRecruiting
Nizams Institute of Medical SciencesHyderabad, Telangana, IndiaNot Yet Recruiting
Osmania Medical CollegeHyderabad, Telangana, IndiaNot Yet Recruiting
Sanjay Gandhi Post Graduate Institute of Medical SciencesLucknow, Uttar Pradesh, IndiaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06676384