Clinical trial NCT00282230: A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
Official title: A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Prograf®/FK778 and Prograf®/MMF in De Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Transplantation
Keywords: Malononitrilamide
immunosuppression
treatment efficacy
treatment outcome
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-01-26
Enrollment: 150
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 evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients


Eligibility criteria: Inclusion Criteria:

* Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
* Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.

Exclusion Criteria:

* Patient has received or is receiving an organ transplant other than kidney
* Patient has received a kidney transplant from a cadaveric donor \>= 60 years of age.

Primary outcomes:
measure: Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
Secondary outcomes:
measure: 6 month patient and graft survival rates
measure: time to first biopsy confirmed acute rejection
measure: clinically treated acute rejection episodes
measure: treatment failure (up to 6 months)
measure: renal function (SrCl and CrCl)
measure: quantitation of CMV and polyomavirus viral load
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: New Brunswick
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Harrisburg
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Astellas Pharma US, Inc.
name: John Holman, MD
role: STUDY_DIRECTOR
References: