Phase 3
Completed N=30
Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
Renal Transplantation
Source: ClinicalTrials.gov NCT00425308 ↗
Enrolled (actual)
30
Serious AEs
60.0%
Results posted
Apr 2011
Primary outcomePrimary: Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. — -4.07; 10.30 (mL/min)
Summary
Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. |
-4.07; 10.30 | — |
| PRIMARY Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial |
1.46; 12.00 | — |
| SECONDARY Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 |
161.7; 153.2; 156.6; 138.9; 170.8; 139.8 | — |
| SECONDARY Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 |
56.3; 60.3; 57.3; 67.1; 50.3; 68.1 | — |
| SECONDARY Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 |
0.44; 0.47; 0.53; 0.24; 0.44; 0.33 | — |
| SECONDARY Assessing Cardiovascular Risk Factors Based on Fasting Glucose. |
5.5; 5.2; 5.2; 5.3; 5.6; 5.2 | — |
| SECONDARY Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. |
5.7; 6.0; 5.0; 5.7; 5.3; 5.6 | — |
| SECONDARY Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. |
3.4; 3.1; 1.5; 1.5; 3.2; 3.4 | — |
| SECONDARY Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. |
2.4; 1.8; 2.1; 2.0; 2.0; 2.2 | — |
| SECONDARY Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). |
11.4; 3.0; 6.3; 10.3; 8.0; 5.6 | — |
Eligibility Criteria
Inclusion criteria
- Patients who participated in and completed study CRAD001A2420
Exclusion criteria
- Premature study or study treatment discontinuation in CRAD001A2420 study.
- Acute rejection within the 3 months prior to inclusion
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00425308). 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.