Status:

COMPLETED

Optimizing Prograf® Therapy in Renal Transplant Patients

Lead Sponsor:

Astellas Pharma Inc

Collaborating Sponsors:

Astellas Pharma US, Inc.

Conditions:

Renal Transplantation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2006

Estimated Enrollment :

323 Patients enrolled

Trial Details

Trial ID

NCT00297765

Start Date

January 1 2003

End Date

March 1 2006

Last Update

August 26 2008

Active Locations (42)

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Page 1 of 11 (42 locations)

1

Birmingham, Alabama, United States, 35294

2

Little Rock, Arkansas, United States, 72205

3

Los Angeles, California, United States, 90057

4

Palo Alto, California, United States, 94304