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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
History of Changes
  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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Los Angeles, California, United States, 90057
Palo Alto, California, United States, 94304
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
United States, Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Georgia
Atlanta, Georgia, United States, 30309
Augusta, Georgia, United States, 30912
United States, Hawaii
Honolulu, Hawaii, United States, 96817
United States, Illinois
Peoria, Illinois, United States, 61603
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Shreveport, Louisiana, United States, 71103
United States, Maine
Portland, Maine, United States, 04102
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Livingston, New Jersey, United States, 07039
West Orange, New Jersey, United States, 07052
United States, New York
Buffalo, New York, United States, 14203
Long Island, New York, United States, 11794
Mineola, New York, United States, 11501
New York, New York, United States, 10032
New York, New York, United States, 10016
New York, New York, United States, 10021
United States, North Carolina
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19141
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75204
Galveston, Texas, United States, 77555
San Antonio, Texas, United States, 78284
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99208
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 May 23, 2013