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Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

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ClinicalTrials.gov Identifier: NCT00297765
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : August 26, 2008
Sponsor:
Collaborator:
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




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, Older Adult)
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.

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.

ClinicalTrials.gov 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
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