Efficacy and Safety of Mycophenolate Mofetil in Refractory IgA Nephropathy

Sponsor
Shaheed Suhrawardy Medical College and Hospital
Study ID
NCT07785128
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mycophenolate Mofetil (MMF) — DRUG
    dministered orally at a total daily dose of 1.5 g in divided doses for a duration of 6 months. Dose adjustment permitted at the discretion of the treating physician in the event of adverse effects.
  • Prednisolon — DRUG
    Administered orally at 0.8 mg/kg/day, followed by a tapering regimen after the study period according to clinical response and tolerability.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
May 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MMF + Standard Care
    Participants will receive mycophenolate mofetil (MMF) 1.5 g/day orally in divided doses for 6 months, in addition to standard supportive care (maximally tolerated ACE inhibitor/ARB therapy, blood pressure control per guideline targets, lifestyle modification, and additional therapies such as SGLT2 inhibitors or statins when clinically indicated). Dose adjustment is permitted at the treating physician's discretion in the event of adverse effects.
  • Active Comparator: Prednisolone + Standard Care
    Participants will receive oral prednisolone 0.8 mg/kg/day, followed by a tapering regimen after the study period according to clinical response and tolerability, in addition to the same standard supportive care described for Arm 1.

Primary Outcome Measure

Proportion of participants achieving complete remission [ Time Frame: 6 months ]

Central Contacts

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