Clinical trial NCT00113269: Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
Official title: Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Treatment Effectiveness
Treatment Efficacy
Anti-rejection therapy
Immunosuppression
Therapy, antirejection
Renal Transplantation
Transplantation, Kidney
Transplantation, Renal
Grafting, Kidney
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-06-08
Enrollment: 501
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: The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Detailed description: A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Eligibility criteria: Inclusion Criteria:

* Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney
* Patient receiving chronic steroid therapy at time of transplant

Primary outcomes:
measure: Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Overall Patient Incidence of BCAR
timeFrame: End of Study (36 months)
measure: Efficacy Failure
timeFrame: End of Study (36 months)
measure: Clinically Treated Acute Rejection
timeFrame: End of Study (36 months)
measure: Time to First BCAR
timeFrame: End of Study (36 months)
measure: Graft Survival at 12 Months
timeFrame: 12 months
measure: Overall Graft Survival
timeFrame: End of Study (36 months)
measure: Patient Survival at 12 Months
timeFrame: 12 months
measure: Overall Patient Survival
timeFrame: End of Study (36 months)
measure: Renal Function Abnormalities Based on Creatinine Clearance
timeFrame: 1 month and End of Study (36 months)
measure: Renal Function Abnormalities Based on Serum Creatinine
timeFrame: 1 month and End of Study (36 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
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: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Livingston
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Hawthorne
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: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Danville
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
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 Global Development
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546.