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.
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
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
Parallel
Mycophenolate Mofetil (MMF)
Drugdministered 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
DrugAdministered orally at 0.8 mg/kg/day, followed by a tapering regimen after the study period according to clinical response and tolerability.
Proportion of participants achieving complete remission
Complete remission defined as 24-hour urinary protein excretion \<0.5 g/day combined with stable renal function (eGFR change within 10% of baseline and no requirement for renal replacement therapy)
Proportion of participants achieving partial remission
Defined as ≥50% reduction in 24-hour urinary protein excretion from baseline, with a final value \<1.0 g/day
Change in 24-hour urinary protein excretion
Absolute change calculated as 6-month value minus baseline value, measured via 24-hour urine collection
Change in serum creatinine
Difference between follow-up and baseline serum creatinine, measured by standardized laboratory methods
Change in estimated glomerular filtration rate (eGFR)
Calculated using the CKD-EPI equation; difference between baseline and 6-month values
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Shaheed Suhrawardy Medical College and Hospital
Lead sponsor
National Institute of Kidney Diseases and Urology Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: