Clinical trial NCT00297765: Optimizing Prograf® Therapy in Renal Transplant Patients
Official title: OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal Transplantation
Therapeutics
Treatment Outcome
Safety
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-03-01
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: The effect of conversion from cyclosporine to Prograf-based therapy on renal function
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Peoria
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Portland
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Livingston
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Long Island
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Astellas Pharma US, Inc.
name: John Holman, MD
role: STUDY_DIRECTOR
References: