Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

Astellas

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: Tacrolimus, Prograf®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297765

20-02-002

Details and patient eligibility

About

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

Full 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

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)