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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

February 28, 2006
August 25, 2008
January 2003
Not Provided
The effect of conversion from cyclosporine to Prograf-based therapy on renal function [ Time Frame: 12 months ]
Not Provided
Complete list of historical versions of study NCT00297765 on ClinicalTrials.gov Archive Site
Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival [ Time Frame: 24 months ]
Not Provided
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Optimizing Prograf® Therapy in Renal Transplant Patients
OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)
A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplantation
Drug: Tacrolimus, Prograf®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
March 2006
Not Provided

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297765
20-02-002
Yes
Not Provided
Not Provided
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Astellas Pharma Inc
Astellas Pharma US, Inc.
Study Director: John Holman, MD Astellas Pharma US, Inc.
Astellas Pharma Inc
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP