Optimizing Prograf® Therapy in Renal Transplant Patients

Renal Transplantation Clinical Trial

— OPTIMA  

Official title:

OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297765
• Other study ID #: 20-02-002
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2006
• Last updated: August 25, 2008
• Start date: January 2003
• Est. completion date: March 2006

Study information

• Verified date: December 2007
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Tacrolimus, Prograf®

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of conversion from cyclosporine to Prograf-based therapy on renal function		12 months
Secondary	Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival		24 months