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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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?

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

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? (NCT06676384) is a Phase 4 interventional studying IgA Nephropathy and Renal Insufficiency, Chronic, sponsored by Christian Medical College, Vellore, India. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 longer-term agents. The KDIGO guidelines development body on glomerular diseases has actively advocated enrolling patients prospectively in 'Clinical Trials'. Platform trials are Multi-Arm and Multi-Stage (MAMS) randomised CTs comparing multiple parallel interventional groups against standardised common control groups with central coordination. It allows new interventions to be added, the control group to be updated throughout the trial, and the use of prespecified interim analysis plans for statistical efficiencies. Interventional groups can be introduced after the trial has started based on pre-specified criteria, and futile interventions may be stopped based on pre-specified interim analyses and trial-stopping rules. This is a randomised controlled single-blind (outcome assessor) Platform trial, Multi-Arm and Multi-Stage. There is a single overarching protocol called a Master protocol. The master protocol, the common concurrent control arm for multiple interventions,the within-trial adaptations, the pre-specified interim analyses, and the pragmatic nature ensure greater acceptability and allow key trial characteristics to evolve. The overall strategy of the study relies strongly on pragmatic 'real world clinical situations' faced by practising nephrologists when treating adult patients with kidney biopsy-proven primary IgAN in South Asia. It will establish the 'GRACE Clinical Trial Network'. The overarching trial hypothesis is that commonly available and approved generic drugs (low-dose oral prednisolone, gut-directed budesonide, mycophenolate mofetil, and hydroxychloroquine) in addition to Standard of Care (SoC), which is the maximal labelled or tolerated dose of renin-angiotensin system blockers (ACEi/ ARB) and a steady dose of sodium-glucose cotransporter 2 inhibitors (SGLT2i) can significantly improve the kidney outcomes at two years when compared to Standard of Care (SoC) alone in South Asian kidney biopsy-proven adult (≥18 years) primary IgAN who on follow-up remain at high risk of progression defined as UPCR ≥0.75g/g and baseline eGFR ≥20ml/min/1.73m2 despite good BP control. SoC is defined as a maximal labelled or tolerated dose of ACEi/ ARB and a steady dose of SGLT2i with a goal BP \<140/90 mmHg for at least three months.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 585 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Must be able to provide a written willing to sign a consent form 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. Who Should NOT Join This Trial: 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Oral prednisolone and SoC

Oral prednisolone 0.5 mg/kg per day (maximum, 40 mg/day) for two months, followed by dose tapering by 5mg per day each month for six to nine months. All participants in this arm will receive SoC and oral cotrimoxazole prophylaxis.

DRUG

Gut-directed budesonide and SoC

Gut-directed Budesonide 12 mg once daily for nine months and tapered to 9mg once daily for the next three months, 6mg once daily for the next three months and 3mg once daily for the next three months and stopped (total 18 months). All participants in this arm will receive SoC.

DRUG

Mycophenolate mofetil (MMF) and SoC

Mycophenolate mofetil (MMF) 1.5g/ day for twelve months, followed by 1g/ day for six months (total 18 months). All participants in this arm will receive SoC.

DRUG

Hydroxychloroquine and SoC

Hydroxychloroquine (HCQ) 6.5 mg/kg/day (maximum 400 mg daily) for 24 months. All participants in this arm will receive SoC.

DRUG

Non-steroidal mineralocorticoid receptor antagonist and SoC

Generic drug not available currently. All participants in this arm will receive SoC.

DRUG

SoC defined as maximal labelled or tolerated dose of angiotensin-converting enzyme inhibitor/ angiotensin receptor blocker (ACEi/ARB) & steady dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i)

Maximal labelled or tolerated dose of ACEi/ ARB and a steady dose of SGLT2i (10mg/d of dapagliflozin).

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
JSS Medical College
Mysuru, Karnataka, India
Kasturba Medical College, Manipal
Udupi, Karnataka, India
KEM Hospital
Mumbai, Maharashtra, India
Safdarjung Hospital, Ansari Nagar East
Delhi, New Delhi, India
AIIMS Bhubaneswar
Bhubaneswar, Odisha, India
JIPMER, JIPMER Campus
Puducherry, Puducherry, India
Madras Medical College
Chennai, Tamil Nadu, India
Christian Medical College Vellore
Vellore, Tamil Nadu, India
Nizams Institute of Medical Sciences
Hyderabad, Telangana, India
Osmania Medical College
Hyderabad, Telangana, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06676384), the sponsor (Christian Medical College, Vellore, India), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06676384 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06676384?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06676384?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06676384. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06676384. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.