Summary
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. ClinicalTrials.gov lists 8 registered trials linking Cyclosporine to Chronic Kidney Disease: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00812123). The largest enrolment is 738 participants (NCT00256750). Registration activity spans 1999 to 2006. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 3 systematic reviews, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2013 to 2026. 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 Chronic Kidney Disease ranks 534 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: GFR decline averages 2-5 mL/min/year on standard care (ACE/ARB + blood pressure control); progression to end-stage renal disease (ESRD) in ~20-30% at 10 years for moderate CKD; reversal essentially impossible once structural fibrosis established.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 74.0 (trials 24.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 systematic reviews, 2 randomised controlled trial publications, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00812123 | Calcineurin Free Immunosuppression in Renal Transplant Recipients 2001 | completed | Phase 4 | 127 |
| NCT00493194 | Fibrosis in Renal Allografts 2005 | status unknown | Phase 4 | 100 |
| NCT00256750 | Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT) 2005 | completed | Phase 3 | 738 |
| NCT00005113 | A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant 1999 | terminated | Phase 3 | 102 |
| NCT00698685 | Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation 2006 | terminated | Phase 2 | 14 |
| NCT00854139 | Combined Bone Marrow Transplantation (BMT) and Renal Transplant for Multiple Myeloma (MM) With End Stage Renal Disease (ESRD) 2001 | completed | Phase 1 | 10 |
| NCT00027820 | Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer 2001 | completed | PHASE1, PHASE2 | 106 |
| NCT00365287 | Combination Chemotherapy and Total-Body Irradiation Before Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer, Metastatic Breast Cancer, or Kidney Cancer 2000 | completed | PHASE1, PHASE2 | 148 |
Published literature
- Systematic review Kidney transplantation in Africa: a systematic review of treatment outcomes, and strategies for enhancing care and sustainabilityAnthony CS, Ogieuhi IJ, Ajekiigbe VO et al. · International urology and nephrology · 2026 · PMID 41162779
- Systematic review Immunosuppressive therapy and nutritional diseases of patients after kidney transplantation: a systematic reviewKajdas AA, Kleibert M, Normann AK et al. · BMC nephrology · 2025 · PMID 39838284
- Clinical trial publication Obesity is associated with a higher incidence of rejection in patients on belatacept: A pooled analysis from the BENEFIT/BENEFIT-EXT clinical trialsLange NW, King K, Husain SA et al. · American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2024 · PMID 38387620
- Systematic review Pemphigoid diseases in patients with end-stage kidney diseases: pathogenesis and treatmentYang LY, Wang YL, Zuo YG · Frontiers in immunology · 2024 · PMID 39050843
- 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
- Clinical trial publication Comparing Kidney Health Outcomes in Children, Adolescents, and Adults With Focal Segmental GlomerulosclerosisGipson DS, Troost JP, Spino C et al. · JAMA network open · 2022 · PMID 36006643
- Clinical trial publication Successful Induction of Specific Immunological Tolerance by Combined Kidney and Hematopoietic Stem Cell Transplantation in HLA-Identical SiblingsFehr T, Hübel K, de Rougemont O et al. · Frontiers in immunology · 2022 · PMID 35173720
- Clinical trial publication Proteinuria Reduction and Kidney Survival in Focal Segmental GlomerulosclerosisTroost JP, Trachtman H, Spino C et al. · American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021 · PMID 32791086
- Cochrane review Correlation between gene polymorphism and blood concentration of calcineurin inhibitors in renal transplant recipients: An overview of systematic reviewsSu L, Yin L, Yang J et al. · Medicine · 2019 · PMID 31261526
- Clinical trial publication Comparison of de novo IgM and IgG anti-HLA DSAs between belatacept- and calcineurin-treated patients: An analysis of the BENEFIT and BENEFIT-EXT trial cohortsEverly MJ, Roberts M, Townsend R et al. · American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2018 · PMID 29767445
- Cochrane review Association of CYP3A4*1B genotype with Cyclosporin A pharmacokinetics in renal transplant recipients: A meta-analysisWang CE, Lu KP, Chang Z et al. · Gene · 2018 · PMID 29678659
- Randomized controlled trial Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapySommerer C, Duerr M, Witzke O et al. · American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2018 · PMID 29722128
- Randomized controlled trial Posttransplant reduction in preexisting donor-specific antibody levels after belatacept- versus cyclosporine-based immunosuppression: Post hoc analyses of BENEFIT and BENEFIT-EXTBray RA, Gebel HM, Townsend R et al. · American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2018 · PMID 29573335
- Cochrane review Cyclosporine-based immunosuppressive therapy for patients with steroid-resistant focal segmental glomerulosclerosis: a meta-analysisChiou YY, Lee YC, Chen MJ · Current medical research and opinion · 2017 · PMID 28436233
- Meta-analysis Calcineurin Inhibitor Minimization, Conversion, Withdrawal, and Avoidance Strategies in Renal Transplantation: A Systematic Review and Meta-AnalysisSawinski D, Trofe-Clark J, Leas B et al. · American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2016 · PMID 26990455
- Cochrane review Immunosuppression for membranous nephropathy: a systematic review and meta-analysis of 36 clinical trialsChen Y, Schieppati A, Cai G et al. · Clinical journal of the American Society of Nephrology : CJASN · 2013 · PMID 23449768
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 Chronic Kidney Disease?
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cyclosporine in clinical trials for Chronic Kidney Disease?
ClinicalTrials.gov lists 8 registered trials linking Cyclosporine to Chronic Kidney Disease: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00812123). The largest enrolment is 738 participants (NCT00256750). Registration activity spans 1999 to 2006.
What does the evidence show for Cyclosporine in Chronic Kidney Disease?
Cyclosporine has both completed registered trials and synthesis-level publications linked to Chronic Kidney Disease. 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 2026-07-05. Page built 2026-10-07.