Summary
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lupus Nephritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lupus Nephritis. ClinicalTrials.gov lists 4 registered trials linking Cyclosporine to Lupus Nephritis: 1 has completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT01299922). The largest enrolment is 1200 participants (NCT03791827). Registration activity spans 2002 to 2021. The literature layer holds 6 publications for this pair: 4 Cochrane reviews and 2 systematic reviews. Publication years run from 2011 to 2023. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Lupus Nephritis ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous remission essentially zero in class III/IV LN; progression to ESRD in 10-20% at 10 years on standard therapy; renal flares in 30-50% of patients achieving initial response.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 54.0 (trials 8.0, literature 26.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 3 other |
| Linked publications | 6 (4 Cochrane reviews, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | AGTR1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01299922 | Clinical Trial Treatment in Lupus Nephritis 2011 | withdrawn | Phase 3 | — |
| NCT00976300 | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study 2002 | completed | Phase 2 | 40 |
| NCT03791827 | Multicenter Registry of Pediatric Lupus Nephritis in China 2018 | status unknown | Not applicable | 1,200 |
| NCT04756492 | Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital 2021 | status unknown | Not applicable | 100 |
Published literature
- Cochrane review Efficacy and safety of immunosuppressive agents for adults with lupus nephritis: a systematic review and network meta-analysisJiang N, Jin S, Yu C et al. · Frontiers in immunology · 2023 · PMID 37901212
- Systematic review The efficacy of immunosuppressive drugs induction therapy for lupus nephritis: a systematic review and network meta-analysisDong Y, Shi J, Wang S et al. · Renal failure · 2023 · PMID 38087473
- Cochrane review The effect of calcineurin inhibitors in the induction and maintenance treatment of lupus nephritis: a systematic review and meta-analysisZhang X, Ji L, Yang L et al. · International urology and nephrology · 2016 · PMID 26781720
- Systematic review Comparative effectiveness of immunosuppressive drugs and corticosteroids for lupus nephritis: a systematic review and network meta-analysisSingh JA, Hossain A, Kotb A et al. · Systematic reviews · 2016 · PMID 27619512
- Cochrane review Calcineurin inhibitors may be a reasonable alternative to cyclophosphamide in the induction treatment of active lupus nephritis: A systematic review and meta-analysisYang M, Li M, He W et al. · Experimental and therapeutic medicine · 2014 · PMID 24926363
- Cochrane review [Meta-analysis of calcineurin inhibitor in the treatment of lupus nephritis]Zhou DJ, Wu XC · Zhonghua er ke za zhi = Chinese journal of pediatrics · 2011 · PMID 21624207
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AGTR1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cyclosporine approved for Lupus Nephritis?
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lupus Nephritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lupus Nephritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cyclosporine in clinical trials for Lupus Nephritis?
ClinicalTrials.gov lists 4 registered trials linking Cyclosporine to Lupus Nephritis: 1 has completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT01299922). The largest enrolment is 1200 participants (NCT03791827). Registration activity spans 2002 to 2021.
What does the evidence show for Cyclosporine in Lupus Nephritis?
Cyclosporine has both completed registered trials and synthesis-level publications linked to Lupus Nephritis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AGTR1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.