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

Phase 3

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00531440
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2005-08
• Study First Submitted: 2007-09-17
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-18
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland