Optimizing Prograf® Therapy in Renal Transplant Patients

Phase 4

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00297765
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

Detailed Description

A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study Completion: 2006-03
• Study First Posted: 2006-03-01
• Status Verified: 2007-12
• Last Update Submitted: 2008-08-25
• Last Update Posted: 2008-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Patient was 18 years of age at the time of transplant.
• Patient is at least 6 months post-transplant.

Exclusion Criteria

• Patient is the recipient of a solid organ transplant other than the kidney.
• Patient is a known carrier of any of the HIV viruses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The effect of conversion from cyclosporine to Prograf-based therapy on renal function	12 months

Secondary Outcome Measures

Name	Time	Method
Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival	24 months