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Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297765
First Posted: March 1, 2006
Last Update Posted: August 26, 2008
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.
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: None (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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00297765     History of Changes
Other Study ID Numbers: 20-02-002
First Submitted: February 28, 2006
First Posted: March 1, 2006
Last Update Posted: August 26, 2008
Last Verified: December 2007

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action