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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2006

Last Updated Date

August 25, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The effect of conversion from cyclosporine to Prograf-based therapy on renal function [ Time Frame: 12 months ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00297765 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival [ Time Frame: 24 months ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optimizing Prograf® Therapy in Renal Transplant Patients

Official Title ^ICMJE

OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

Brief Summary

A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Transplantation

Intervention ^ICMJE

Drug: Tacrolimus, Prograf®

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

323

Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00297765

Other Study ID Numbers ^ICMJE

20-02-002

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Astellas Pharma US, Inc.

Investigators ^ICMJE

Study Director:

John Holman, MD

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

December 2007

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

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