Phase 4
N=116
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Graft Rejection · Kidney Failure
Bottom Line
View on ClinicalTrials.gov: NCT00369382 ↗Enrolled (actual)
116
Serious AEs
37.7%
Results posted
May 2011
Primary outcome: Primary: Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization — -1.35; 3.03 mL/min/1.73m^2 — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- cyclosporine or tacrolimus (Drug); sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization |
-1.35; 3.03 | 0.004 sig |
| PRIMARY Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline |
57.09; 57.75 | — |
| SECONDARY Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization |
-0.20; 2.96; -2.16; 3.79; -1.91; 2.15 | 0.018 sig |
| SECONDARY Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization |
-0.00; 3.18; -1.92; 4.30; -1.47; 2.54 | 0.031 sig |
| SECONDARY Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline |
55.39; 54.47 | — |
| SECONDARY Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization |
1.68; -4.95; 7.96; -5.52; 8.02; -0.89 | 0.009 sig |
| SECONDARY Serum Creatinine Level at Baseline |
125.42; 126.21 | — |
| SECONDARY Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation) |
-0.740; 1.571 | 0.126 |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Number of Participants With Acute Rejection |
1; 5; 0; 2; NA; 7 | 0.206 |
| SECONDARY Number of Participants With Biopsy-confirmed Acute Rejection by Severity |
NA; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to First Acute Rejection |
— | — |
| SECONDARY Number of Participants Requiring Antibody Use in Treatment of Acute Rejection |
1; 0 | — |
| SECONDARY Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy |
21 | — |
Summary
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.
Eligibility Criteria
Inclusion Criteria
- Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
- 12 months after cardiac transplantation but less than 96 months post-transplantation.
Exclusion Criteria
- Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
- Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
- History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.
Data sourced from ClinicalTrials.gov (NCT00369382). 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.