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Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: basiliximab (Drug); rabbit anti-thymocyte globulin (Drug); tacrolimus (Drug); alemtuzumab (Drug); mycophenolate mofetil (Drug); steroids (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma Global Development

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months

Secondary outcome:

Overall Patient Incidence of BCAR

Efficacy Failure

Clinically Treated Acute Rejection

Time to First BCAR

Graft Survival at 12 Months

Overall Graft Survival

Patient Survival at 12 Months

Overall Patient Survival

Renal Function Abnormalities Based on Creatinine Clearance

Renal Function Abnormalities Based on Serum Creatinine

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Birmingham, Alabama 35294, United States

Los Angeles, California 90057, United States

Palo Alto, California 94304, United States

San Diego, California 92123, United States

San Francisco, California 94115, United States

San Francisco, California 94143, United States

Denver, Colorado 80262, United States

Washington, District of Columbia 20007, United States

Washington, District of Columbia 20010, United States

Miami, Florida 33136, United States

Tampa, Florida 33066, United States

Chicago, Illinois 60611, United States

Chicago, Illinois 60612, United States

Livingston, New Jersey 07039, United States

New Brunswick, New Jersey 08901, United States

Hawthorne, New York 10532, United States

New York, New York 10029, United States

New York, New York 10032, United States

Chapel Hill, North Carolina 27599, United States

Durham, North Carolina 27710, United States

Cincinnati, Ohio 45267, United States

Portland, Oregon 97239, United States

Danville, Pennsylvania 17822, United States

Harrisburg, Pennsylvania 17105, United States

Charleston, South Carolina 29425, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84132, United States

Madison, Wisconsin 53792, United States

Milwaukee, Wisconsin 53226, United States

Additional Information

Link to Prescribing Information

Related publications:

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.

Starting date: May 2005
Last updated: August 9, 2011

Page last updated: August 23, 2015

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