A Phase 2 interventional study of Mycophenolate Mofetil (MMF) and Prednisolon in IgA Nephropathy, sponsored by Shaheed Suhrawardy Medical College and Hospital. Not yet recruiting at 3 sites in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Shaheed Suhrawardy Medical College and Hospital · Phase 2, Interventional, and Treatment
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.
IgA nephropathy is one of the most common forms of primary glomerulonephritis worldwide, with disease burden concentrated in Asia. In Bangladesh, epidemiological data remain limited, though hospital-based biopsy series suggest it accounts for roughly 5-10% of biopsy-proven primary glomerular disease. A subset of patients fail to achieve adequate reduction in proteinuria despite optimized renin-angiotensin-system blockade and a course of corticosteroid therapy; this refractory phenotype carries an elevated long-term risk of progression to end-stage kidney disease and currently lacks a clearly defined, evidence-based treatment pathway.
Mycophenolate mofetil (MMF), a selective and reversible inhibitor of inosine monophosphate dehydrogenase, suppresses T- and B-lymphocyte proliferation and has shown biological plausibility for reducing pathogenic galactose-deficient IgA1 immune complex formation in IgA nephropathy. However, clinical trial results to date have been markedly heterogeneous by population: several Chinese cohort studies report meaningful reductions in proteinuria and renal protection, while Western multicentre randomized trials have largely shown neutral or inconclusive results. This geographic divergence has shaped conditional, population-specific guidance in current KDIGO recommendations. No randomized trial has yet evaluated MMF in a South Asian population, where genetic background, immune response profiles, and healthcare delivery context differ from both previously studied East Asian and Western cohorts.
This trial is designed to generate the first prospective, randomized evidence on MMF for refractory IgA nephropathy in a Bangladeshi population, using an active comparator (prednisolone) rather than placebo, reflecting that corticosteroid-based therapy remains the existing standard of care in this setting. MMF was selected as the intervention of interest because it is already available, relatively affordable, and familiar to local nephrologists through established use in transplant medicine, making it a pragmatic candidate for repurposing should efficacy be demonstrated locally - in contrast to newer agents (e.g., targeted-release budesonide, complement inhibitors) that remain largely inaccessible in this setting due to cost and regulatory constraints.
Randomization will use a block design (block size of 6) generated by a computer-based program to maintain balanced allocation across the two arms throughout the enrollment period. As this is an open-label trial with no blinding, outcome assessments rely on objective laboratory measures (24-hour urinary protein, serum creatinine, eGFR by the CKD-EPI equation) rather than subjective clinician-rated endpoints, to limit the impact of unblinding on result interpretation.
Statistical analyses will be performed on an intention-to-treat basis, with a per-protocol analysis conducted as a supplementary sensitivity analysis. Binary outcomes will be modeled using generalized linear mixed-effects models with a logit link, adjusting for baseline proteinuria, baseline eGFR, age, and sex, with treatment effects expressed as adjusted odds ratios and model-based marginal risk differences. Continuous outcomes will be analyzed using linear mixed-effects models with random intercepts for participants to account for within-subject correlation across repeated measures. The composite renal outcome will be analyzed using Kaplan-Meier estimation with Cox proportional hazards regression. Missing data will be handled under a missing-at-random assumption using maximum likelihood estimation within the mixed models, supplemented by multiple imputation and complete-case sensitivity analyses.
Independent oversight will be provided by a Data and Safety Monitoring Board comprising a nephrologist, medicine specialist, epidemiologist, and statistician not otherwise involved in the trial, reviewing interim safety and efficacy data at three-monthly intervals.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 104 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →This is the only study on the registry with Shaheed Suhrawardy Medical College and Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Mycophenolate Mofetil (MMF)
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.
Drug: Prednisolon
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.
Administered 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)
Time frame: 6 months
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
Time frame: 6 months
Change in 24-hour urinary protein excretion
Absolute change calculated as 6-month value minus baseline value, measured via 24-hour urine collection
Time frame: 6 months
Change in serum creatinine
Difference between follow-up and baseline serum creatinine, measured by standardized laboratory methods
Time frame: 6 months
Change in estimated glomerular filtration rate (eGFR)
Calculated using the CKD-EPI equation; difference between baseline and 6-month values
Time frame: 6 months
Proportion of participants achieving proteinuria <1.0 g/day
Assessed via 24-hour urinary protein excretion at 6 months
Time frame: 6 months
Proportion of participants with ≥30% decline in eGFR
Percentage decline calculated from baseline to 6 months
Time frame: 6 months
Composite renal outcome
First occurrence of any of: ≥30% decline in eGFR from baseline, doubling of serum creatinine, or initiation of renal replacement therapy
Time frame: 6 months
Proportion of patients reporting treatment-related adverse events
Documented from time of informed consent through the last per-protocol visit
Time frame: 6 months
Proportion of patients reporting serious adverse events (SAEs)
As defined by death, life-threatening event, persistent disability, prolonged hospitalization, or important medical event, per protocol definitions
Time frame: 6 months
Plan to share: Undecided — No plan currently exists to share individual participant data outside the study team. This may be reconsidered following study completion
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.
Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mycophenolic Acid