This is a 2-year Follow-up Study to Evaluate the Long-term Effects in Patients Who Completed the Study CRAD001A2307.

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00531440
• Collaborator: (none)
• Enrollment: 256
• Location: 1

Study Details

Study Description

Brief Summary

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Everolimus (RAD001)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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 (RAD001) With Basiliximab, Corticosteroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate []

Secondary Outcome Measures

1. biopsy-proven acute rejection episodes,graft loss, deathor lost to follow-up 6,12,24&3677 Mths both groups.assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, clinically-confirmed acute rejection. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patients who are receiving study medication at Month 12 (CRAD001A2307) and sign a new Informed Consent to extend the treatment or observation period beyond Month 12.

• Female 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 cannot enter the extension.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis	Basel		Switzerland

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00531440
• Other Study ID Numbers: CRAD001A2307E1
• First Posted: Sep 18, 2007
• Last Update Posted: Nov 2, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Novartis Pharmaceuticals: Renal transplantation, everolimus, Immunosuppressants
• Additional relevant MeSH terms: Everolimus

Study Results

No Results Posted as of Nov 2, 2011