Optimizing Prograf® Therapy in Renal Transplant Patients

OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00297765

Acronym

OPTIMA

Enrollment

323

Registered

2006-03-01

Start date

2003-01-31

Completion date

2006-03-31

Last updated

2008-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

Renal Transplantation, Therapeutics, Treatment Outcome, Safety

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

Interventions

DRUGTacrolimus, Prograf®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The effect of conversion from cyclosporine to Prograf-based therapy on renal function	12 months

Secondary

Measure	Time frame
Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival	24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026