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Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

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

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

  Show 42 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Study Director: John Holman, MD Astellas Pharma US, Inc.
  More Information Identifier: NCT00297765     History of Changes
Other Study ID Numbers: 20-02-002
Study First Received: February 28, 2006
Last Updated: August 25, 2008

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 processed this record on May 25, 2017