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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
February 28, 2006
March 1, 2006
August 26, 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
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: None (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.
Sexes Eligible for Study: All
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
Not Provided
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