Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297765
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : August 26, 2008
Astellas Pharma US, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Tacrolimus, Prograf® Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)
Study Start Date : January 2003
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297765

  Hide Study 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, 10016
New York, New York, United States, 10021
New York, New York, United States, 10032
United States, North Carolina
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19141
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.
Study Director: John Holman, MD Astellas Pharma US, Inc. Identifier: NCT00297765     History of Changes
Other Study ID Numbers: 20-02-002
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: December 2007

Keywords provided by Astellas Pharma Inc:
Renal Transplantation
Treatment Outcome

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action