Lupus kidney patients may be able to ditch heavy meds after two years
NCT ID NCT01284725
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at whether people with lupus-related kidney inflammation (lupus nephritis) who have been stable for two years can safely stop taking immunosuppressive drugs like mycophenolate mofetil or azathioprine. One hundred patients were split into two groups: one continued the drugs, the other stopped. Everyone kept taking hydroxychloroquine and possibly low-dose steroids. The goal was to see if stopping treatment led to more kidney flare-ups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mycophenolate mofetil or azathioprine
- What this could lead to
- If successful, this could show that some lupus nephritis patients can safely stop long-term immunosuppressive drugs, reducing side effects and medication burden.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all patients. Stopping immunosuppression could increase the risk of lupus flare-ups or kidney damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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100 people
The number who actually took part.
- Started
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Feb 2011
- Finished
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Dec 2018
- 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 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * At least 18-years-old patient, woman or man, * Patient having a lupus according to the criteria of the ACR, * Patient having presented a glomérulonéphrite lupique proliférative (class III or IV Has +/-C, +/-list(classify) V) - first push or relapse - proved by renal biopsy, * Patient having received for this push a treatment of attack by steroids with strong doses and cyclophosphamide or mycophénolate mofétil, * Patient in the course of treatment of interview(maintenance) by azathioprine or mycophénolate mofétil for at least 2 years, and at most for 3 years, with at the time of the inclusion, mycophénolate mofétil? 1 gram / day or azathioprine? 50 in the daytime, * Patient in reply renal complete or partial (criteria of the European, secondary consensus 2) since? 12 months, * Patient under Plaquenil ® since? 6 months with a hydroxychloroquinémie = 750 µg / L, * Patient having accepted of participated in the study and having signed a lit(enlightened) consent. Exclusion Criteria: * Patient presenting a severe chronic renal insufficiency (DFG estimated(esteemed) by MDRD \< 30 ml / min / 1.73m ²), * Patient having presented an extra-renal push having required an increase of corticoids à\> 20 in the daytime during at least 7 days less than 6 months ago, * Patient presenting a contraindication to the hydroxychloroquine, * Unaffiliated patient in a national social security, * Minor patient.
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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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Assistance Publique Hopitaux de Marseille
Marseille, 13354, France