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Efficacy and Safety of Mycophenolate Mofetil in Refractory IgA Nephropathy

NCT07785128 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-08-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Mycophenolate Mofetil (MMF)

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.

DRUG

Prednisolon

Administered orally at 0.8 mg/kg/day, followed by a tapering regimen after the study period according to clinical response and tolerability.

Sponsors & Collaborators

  • National Institute of Kidney Diseases and Urology Hospital

    collaborator UNKNOWN

  • Shaheed Suhrawardy Medical College and Hospital

    lead OTHER

Principal Investigators

  • Mohammad Naheed Hasan · Shaheed Suhrawardy Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-05-30
Completion
2027-08-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785128 on ClinicalTrials.gov