Clinical trial · Interventional
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease
NCT02134899CI-TRIAL-00036067EVERKYSTEcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autosomal Dominant Polycystic Kidney Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcineurin inhibitors maintenance | Drug | — | UNRESOLVED |
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- everolimus based immunosuppression
- interventionNames
- Drug: Everolimus
- type
- ACTIVE_COMPARATOR
- label
- Calcineurin
- description
- Calcineurin inhibitors maintenance
- interventionNames
- Drug: Calcineurin inhibitors maintenance
Primary outcomes (1)
- measure
- Total native kidney volume variation
- timeFrame
- 24 months after randomization
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 75 years-old * recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2 * contraception for female recipients to avoid pregnancy * valid health Insurance during the study period Exclusion Criteria: * signed informed consent not obtained
References
Publications (0)
Data not yet available
No reference posted for this study.