Kidney disease drug combo shows promise in small trial
NCT ID NCT04743739
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether adding cyclosporine to rituximab is more effective than rituximab alone for treating idiopathic membranous nephropathy, a kidney disease that causes protein leakage. Only 12 adults with severe proteinuria took part before the study ended early. The goal was to see if the combination led to complete or partial remission, meaning less protein in urine and better blood protein levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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12 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * idiopathic MN with or without diagnostic biopsy * Female, must be post-menopausal, sterile or have effective method of contraception * must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for \> 6 months * Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥3 months prior to randomization with controlled blood pressure or if patients is intolerant to ACEI/ARB * proteinuria ≥4g/24h using the average from two 24-hour urine samples collected within 2 weeks of each other, and decreased ≤50% from baseline. * estimated glomerular filtration rate (eGFR) ≥40ml/min/1.73m2 Exclusion Criteria: * presence of active infection or a secondary cause of MN * diabetes mellitus: to exclude proteinuria secondary to diabetic nephropathy. * pregnancy or breast feeding * history of resistance to CsA or other calcineurin inhibitors(CNI), RTX or alkylating agents. * Patients who previously achieved remission after treatment of CNI, RTX or alkylating agents but relapsed off CNI after 3 months, or relapsed off RTX or alkylating agents after 6 months, are eligible.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
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Nanyang Nanshi Hospital, Henan University
Nanyang, Henan, 473065, China
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
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The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Shenzhen, China
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