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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00113269

Purpose

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.

Condition	Intervention	Phase
Kidney Transplantation	Drug: basiliximab Drug: rabbit anti-thymocyte globulin Drug: tacrolimus Drug: alemtuzumab	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus Campath Basiliximab Alemtuzumab

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

The incidence of biopsy-confirmed acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient and graft survival rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	502
Study Start Date:	May 2005
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tacrolimus oral Drug: alemtuzumab IV
2: Experimental	Drug: basiliximab IV Drug: rabbit anti-thymocyte globulin IV Drug: tacrolimus oral

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113269

Show 29 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Global Development ( Sr Manager Clinical Trial Registries )
Study ID Numbers:	20-04-003
Study First Received:	June 7, 2005
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00113269 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:

Treatment Effectiveness
Treatment Efficacy
Anti-rejection therapy
Immunosuppression
Therapy, antirejection

Renal Transplantation
Transplantation, Kidney
Transplantation, Renal
Grafting, Kidney

Study placed in the following topic categories:

Antilymphocyte Serum
Basiliximab
Immunologic Factors

Alemtuzumab
Tacrolimus
Immunosuppressive Agents

Additional relevant MeSH terms:

Antilymphocyte Serum
Basiliximab
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Alemtuzumab
Physiological Effects of Drugs
Tacrolimus
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 30, 2009