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Which approved add-on drugs slow kidney decline in South-Asian adults with biopsy-proven IgA nephropathy?

Randomized Embedded Adaptive Platform Clinical Trial in South Asian Kidney Biopsy-Proven Primary IgA Nephropathy: Multi-center, Multi-arm and Multi-stage

PHASE4 · Christian Medical College, Vellore, India · NCT06676384

This trial will test whether adding one of several approved oral medications to standard care can slow kidney function loss over two years in South-Asian adults with biopsy-proven IgA nephropathy.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment585 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorChristian Medical College, Vellore, India (other)
Drugs / interventionsbelimumab, rituximab, ocrelizumab, cyclophosphamide
Locations12 sites (Nadiād, Gujarat and 11 other locations)
Trial IDNCT06676384 on ClinicalTrials.gov

What this trial studies

This is a multi-center, randomized platform trial comparing several commonly available, approved oral medications added to standard-of-care therapy versus standard-of-care alone in adults with biopsy-confirmed IgA nephropathy. Participants are randomized to arms including oral prednisolone, gut-directed budesonide, mycophenolate mofetil, hydroxychloroquine, or a non-steroidal mineralocorticoid receptor antagonist, all on top of background ACEi/ARB and dapagliflozin where tolerated. The primary outcome is the slope of estimated glomerular filtration rate (eGFR) over two years. Sites are in India and the trial targets South-Asian patients to address previously observed rapid progression in this population.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 years with biopsy-proven primary IgA nephropathy, eGFR ≥20 mL/min/1.73 m2, significant proteinuria (≥1 g/24 h or UPCR ≥0.75), on maximal tolerated ACEi/ARB plus 10 mg dapagliflozin for at least 12 weeks, and with controlled blood pressure at randomization.

Not a fit: Patients unlikely to benefit include those with advanced kidney failure (eGFR <20), outside the 18–65 age range, without biopsy confirmation, not on the required background therapies, or with contraindications to the study medications.

Why it matters

Potential benefit: If successful, the trial could identify widely available, approved drugs that slow eGFR decline in South-Asian patients with IgA nephropathy and reduce progression to kidney failure.

How similar studies have performed: Some individual agents (for example gut-directed budesonide and corticosteroids) and background SGLT2 inhibitors have shown benefit in prior trials, but results vary by drug and population and a multi-arm platform trial focused on South Asians is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Must be able to provide a written informed consent form, which must be obtained before the initiation of study assessments.
2. Adults between 18-65 years of age.
3. Males or Females.
4. Diagnosis of primary IgAN as demonstrated by renal biopsy of any vintage if eGFR ≥45 mL/min/1.73 m2 or within the last ten years if eGFR \<45 mL/min/1.73 m2. If diabetic, the biopsy vintage should be less than five years.
5. eGFR ≥20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
6. Total urine protein excretion ≥1 g per 24-hour or UPCR ≥ 0.75 g/g from an adequately measured 24-hour urine sample (24HUP) during the Screening Period.
7. Patient on the maximum labelled or tolerated dose of ACEi or ARB AND 10mg/d of Dapagliflozin (SGLT2i) for at least 12 weeks at screening and from screening to study Day 1.
8. Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 mmHg at randomisation. Other anti-hypertensives can be optimised during the screening period to achieve the BP goal.
9. A female is eligible if she is not pregnant and consents to avoid pregnancy during the study duration.

Exclusion Criteria:

1. IgAN secondary to another condition (e.g., liver cirrhosis) or other causes of mesangial IgA deposition such as systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis, etc. IgA vasculitis (i.e., Henoch-Schonlein purpura) with biopsy-proven mesangial IgA deposition and no active skin vasculitis for the last year can be included.
2. Evidence of nephrotic syndrome at screening (serum albumin \<3g/dL AND UPCR \>3.5 g/g).
3. Evidence of rapidly progressive glomerulonephritis defined as loss of ≥ 50% of eGFR in three months before screening.
4. Concomitant kidney disease in addition to IgAN in kidney biopsy (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis).
5. Female patients planning pregnancy.
6. Concomitant co-morbidities like systemic autoimmune disorders, chronic active infections like tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus infection, chronic liver disease, and chronic obstructive pulmonary disease.
7. Renal or other organ transplantation before, or expected during, the study, except for corneal transplants.
8. Morbid obesity defined as BMI ≥ 40 kg/m2 at screening.
9. Uncontrolled diabetes as defined by HbA1c \> 8% at screening.
10. History or diagnosis of demyelinating diseases such as multiple sclerosis or optic neuritis.
11. Prohibited medications:

    * Participants who received oral steroids over two weeks within 12 weeks before screening.
    * Immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for treating IgAN within 12 weeks before screening.
    * Use of B-cell-directed biologic therapies, including belimumab, rituximab, and ocrelizumab, within six months before screening.
    * Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics within the last four weeks or five half-lives, whichever is longer, before the screening.
    * Use of traditional medications and/or Ayurvedic medications within 12 weeks before screening.
    * Use of endothelin receptor antagonists/ oral spironolactone or oral finerenone/ GLP-1 agonists/ hydroxychloroquine within 12 weeks before screening.
12. Patients with a history of unstable angina, Class III and IV congestive heart failure, and clinically significant arrhythmia, as judged by the Investigator.
13. Active clinically significant viral, bacterial, or fungal infection or any major episode of infection requiring hospitalisation or treatment with parenteral anti-infectives within four weeks before or during the Screening Visit.
14. History of malignancy within the past five years before Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence).
15. Known hypersensitivity to any of the interventions.
16. Major surgery within six weeks before the Screening Visit.
17. Clinically significant history of alcohol or drug abuse in the one year before the Screening Visit as per the Investigator's opinion.
18. Unwillingness or lack of capacity to follow all study procedures.

Where this trial is running

Nadiād, Gujarat and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: IgA Nephropathy, Renal Insufficiency, Chronic, IgA Vasculitis, IGA Glomerulonephritis, Platform Trial, Randomised Embedded Trial, MAMS Trial, Chronic kidney disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.