Mycophenolate mofetil for IgA nephropathy that has not improved with standard care
Tests mycophenolate mofetil against prednisolone in adults with treatment-resistant IgA nephropathy.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Mycophenolate Mofetil in Refractory IgA Nephropathy
Key facts
- Where
- Dhaka, BangladeshSee the 3 sites
- Phase
- Phase 2
Where in Bangladesh
- Dhaka Medical College, DhakaDhaka, BangladeshNo longer taking part
- National Institute of Kidney Diseases and UrologyDhaka, BangladeshNo longer taking part
- Shaheed Suhrawardi Medical College HospitalDhaka, BangladeshNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shaheed Suhrawardy Medical College and Hospital
- Trial code
- NCT07785128
- Record updated
- 25 August 2026
- Original description
This study is testing whether a medicine called mycophenolate mofetil (MMF) works better than the usual treatment for people whose kidney disease, called IgA nephropathy, has not improved with standard care.Read full original descriptionShow less
Efficacy and Safety of Mycophenolate Mofetil in Patients With Refractory IgA Nephropathy in Bangladesh: A Phase II Randomized Controlled Trial
This study is testing whether a medicine called mycophenolate mofetil (MMF) works better than the usual treatment for people whose kidney disease, called IgA nephropathy, has not improved with standard care.
IgA nephropathy is a kidney disease that can cause protein to leak into the urine and, over time, can damage the kidneys. Some people with this disease do not get better even after standard treatment. Doctors call this "refractory" disease. Right now, there is no proven best treatment for these patients in Bangladesh.
This study will include 116 adults with kidney disease that has been confirmed by a kidney tissue sample and has not improved with standard treatment. Participants will be split into two equal groups by chance, like a coin flip. One group will take MMF by mouth for 6 months, along with the usual supportive care. The other group will take a steroid medicine called prednisolone, along with the usual supportive care. Both groups will also continue treatments like blood pressure medicines that are already part of standard care for this condition.
Researchers want to find out how many people in each group get better, meaning their urine protein drops to a low level and their kidney function stays stable. They will also look at changes in kidney function and any side effects from the medicines.
The study will take place at the National Institute of Kidney Diseases and Urology Hospital in Dhaka, Bangladesh, over about one year. Each participant will be followed for 6 months, with check-up visits and blood and urine tests at the start, at 3 months, and at 6 months.
Inclusion: Age ≥18 years Biopsy-proven refractory IgA nephropathy, defined as persistent proteinuria >1.0 g/day despite completion of optimized supportive therapy according to KDIGO recommendations, including corticosteroid and/or immunosuppressive therapy and ACE inhibitor and/or angiotensin receptor blocker therapy (unless contraindicated) for a minimum of six months eGFR ≥30 mL/min/1.73 m² at enrollment.
Exclusion: Complete or partial remission of IgA nephropathy at enrollment Secondary IgA nephropathy associated with systemic diseases Diabetes mellitus with diabetic kidney disease or any other known non-IgA cause of proteinuria End-stage renal disease requiring dialysis or previous kidney transplantation eGFR <30 mL/min/1.73 m² at enrollment Active infection requiring systemic antimicrobial therapy Significant hepatic impairment (ALT or AST >3 times the upper limit of normal) Pregnancy, planned pregnancy, or breastfeeding Known hypersensitivity or contraindication to MMF.