N/A
Completed N=60
Comparing Everolimus and Sirolimus in Renal Transplant Recipients
Source: ClinicalTrials.gov NCT01976390 ↗Enrolled (actual)
60
Serious AEs
86.7%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year — 40; 19; 38; 19 Participants
Summary
This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year |
40; 19; 38; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must give written informed consent before any assessment is performed.
- Primary renal transplant recipients between ages 18 and 75 years of age.
- Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable.
Exclusion Criteria
- Total cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite lipid lowering therapy
- Pre-existing bone marrow suppression (White Blood Cell count of < 3000, platelets < 100,000)
- Active infection (Hepatitis B Virus, HIV)
- Malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an Oncologist or if patient has had no malignancy for at least 2 years prior to the transplant
- Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin
Data sourced from ClinicalTrials.gov (NCT01976390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.