Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00297765
First received: February 28, 2006
Last updated: August 25, 2008
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Renal Transplantation
Drug: Tacrolimus, Prograf®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The effect of conversion from cyclosporine to Prograf-based therapy on renal function [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival [ Time Frame: 24 months ]

Enrollment: 323
Study Start Date: January 2003
Study Completion Date: March 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297765

  Show 42 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: John Holman, MD Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00297765     History of Changes
Other Study ID Numbers: 20-02-002
Study First Received: February 28, 2006
Last Updated: August 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Renal Transplantation
Therapeutics
Treatment Outcome
Safety

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014