Phase 3
Completed N=709
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
Source: ClinicalTrials.gov NCT01114529 ↗Enrolled (actual)
709
Serious AEs
51.6%
Results posted
May 2017
Primary outcomePrimary: Estimated Glomerular Filtration Rate (eGFR) — 64.1; 61.5; 58.4 mL/min/1.73m^2
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Glomerular Filtration Rate (eGFR) |
64.1; 61.5; 58.4 | — |
| SECONDARY Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 |
21; 4; 8; 27; 8; 8 | — |
| SECONDARY Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24 |
50.30; 51.08; 51.13; 49.95; 48.98; 50.96 | — |
| SECONDARY Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis) |
27; 8; 8; 35; 14; 15 | — |
Eligibility Criteria
Inclusion Criteria at Baseline:
- Male or female renal allograft recipients at least 18 years old.
- Written informed consent.
- Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor.
- Cold ischemia time (CIT) 1 g/day.
- Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS).
- Low platelet count; Low white blood cell count; Low absolute neutrophil count; Low hemoglobin.
- Severe liver disease.
- Systemic infection requiring continued therapy that would interfere with the objectives of the study.
- Severe hypercholesterolemia or hypertriglyceridemia.
- Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy.
- Presence of intractable immunosuppressant complications or side effects.
- Patients on anticoagulants that prevents renal allograft biopsy.
- Use of prohibited medication.
- Use of immunosuppressive agents not utilized in the protocol.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential not using a highly effective method of birth control.
Data sourced from ClinicalTrials.gov (NCT01114529). 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.