Clinical trial · Interventional
Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer
A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer
NCT00922129CI-TRIAL-00013440withdrawnPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study did not start up as planned.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the role and effectiveness of conversion to sirolimus versus CNI reduction in renal transplant patients with prostate cancer.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclosporin (Neoral) or Tacrolimus (Prograf) | Drug | — | UNRESOLVED |
| Sirolimus (Rapamune) | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conversion to sirolimus
- interventionNames
- Drug: Sirolimus (Rapamune)
- type
- ACTIVE_COMPARATOR
- label
- Calcineurim inhibitor reduction
- interventionNames
- Drug: Cyclosporin (Neoral) or Tacrolimus (Prograf)
Primary outcomes (1)
- measure
- Malignancy-free survival
- timeFrame
- Months 3, 9, 15, 21
Secondary outcomes (3)
- measure
- Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients ≤ 50 years in their post renal transplant follow-up; * Biopsy confirmed prostate cancer; * Stable renal function with GFR ≥ 40 mL/min. Exclusion Criteria: * Patients with metastatic disease; * Uncontrolled hyperlipidemia; * Proteinuria \> 500 mg/day; * Biopsy evidence of acute rejection within the past 3 months; * Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication; * Patients with mental illness; * Inability to cooperate or communicate with the investigator or unable to complete self administered questionnaires.
References
Publications (0)
Data not yet available
No reference posted for this study.