This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00531063
First received: September 17, 2007
Last updated: November 1, 2011
Last verified: November 2011
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Purpose
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Transplantation |
Drug: Everolimus (RAD001) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A 2-year Extension to a 1-year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus With Steroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- • To assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, biopsy-proven chronic allograft nephropathy, retransplantation or dialysis up to 36 months
Secondary Outcome Measures:
- To quantify the incidence of biopsy-proven acute rejection episodes, graft loss, death or lost to follow-up at 6, 12, 24 and 36 months in both groups. To assess the incidence of graft loss, death, biopsy-proven acute rejection,
| Estimated Enrollment: | 237 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Patients who are receiving study medication at Month 12 of the one-year study (CRAD001A2306) and sign a new Informed Consent to extend the treatment and observation period beyond Month 12.
- Females patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
- Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies
- Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.
Exclusion Criteria:
- Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 RAD001A2306)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00531063 History of Changes |
| Other Study ID Numbers: | CRAD001A2306E1 |
| Study First Received: | September 17, 2007 |
| Last Updated: | November 1, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Novartis:
|
Renal transplantation, everolimus, Immunosuppressants |
Additional relevant MeSH terms:
|
Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013