Optimizing Prograf® Therapy in Renal Transplant Patients - Full Text View

Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

This study has been completed.

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00297765

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Link to results disclosure This link exits the ClinicalTrials.gov site

Study ID Numbers:	20-02-002
Study First Received:	February 28, 2006
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00297765
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Renal Transplantation
Therapeutics
Treatment Outcome
Safety

Study placed in the following topic categories:

Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009