NCT07785128Not yet recruitingPhase 2
Efficacy and Safety of Mycophenolate Mofetil in Refractory IgA Nephropathy
Efficacy and Safety of Mycophenolate Mofetil in Patients With Refractory IgA Nephropathy in Bangladesh: A Phase II Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Shaheed Suhrawardy Medical College and Hospital
- Diseases
- IgA nephropathy
- NCT number
- NCT07785128
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 104
- From 1 Sept 2026 to the primary completion date, 30 May 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaheed Suhrawardi Medical College Hospital Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
| National Institute of Kidney Diseases and Urology Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
| Dhaka Medical College, Dhaka Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.