A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00543569

Purpose

A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Alefacept Drug: tacrolimus Drug: basiliximab Drug: mycophenolate mofetil Drug: steroids	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Basiliximab Alefacept

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of biopsy-confirmed acute rejection (BCAR) assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient and graft survival rates [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
BCAR rate by local review [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Serum creatinine [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Glomerular filtration rate (GFR) by Modification of Diet in Renal disease (MDRD) method [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
GFR by iothalamate clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of efficacy failure (based local review of biopsy) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence of efficacy failure (based on central review of biopsy) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Time to first BCAR as assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of clinically-treated acute rejections [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Use of anti-lymphocyte antibody therapy for treatment of rejection [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence of patients experiencing multiple rejection episodes [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence of treatment failure [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence of BCAR assessed by central review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Time to first BCAR, as assessed by central review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of T-cell mediated BCAR assessed by local review [ Time Frame: 6 montha and 12 months ] [ Designated as safety issue: No ]
Incidence of T-cell mediated BCAR assessed by central review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Time to first T-cell mediated BCAR as assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Time to first T-cell mediated BCAR as assessed by central review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Maximum grade of T-cell mediated rejection as assessed by local review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Maximum grade of T-cell mediated rejection as assessed by central review [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment:	323
Study Start Date:	December 2007
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1. Comparator Regimen tacrolimus, basiliximab, MMF, steroids	Drug: tacrolimus Oral Other Name: Prograf, FK506 Drug: basiliximab IV Other Name: Simulect Drug: mycophenolate mofetil Oral Other Name: CellCept, MMF Drug: steroids Oral
Experimental: 2. CNI Reduction alefacept, tacrolimus, MMF, steroids	Drug: Alefacept IV and Sub-cutaneous Other Name: Amevive, ASP0485 Drug: tacrolimus Oral Other Name: Prograf, FK506 Drug: mycophenolate mofetil Oral Other Name: CellCept, MMF Drug: steroids Oral
Experimental: 3. MMF Replacement alefacept, tacrolimus, steroids	Drug: Alefacept IV and Sub-cutaneous Other Name: Amevive, ASP0485 Drug: tacrolimus Oral Other Name: Prograf, FK506 Drug: steroids Oral
Experimental: 4. Alternative Alefacept Dosing alefacept, tacrolimus, MMF, steroids	Drug: Alefacept IV and Sub-cutaneous Other Name: Amevive, ASP0485 Drug: tacrolimus Oral Other Name: Prograf, FK506 Drug: mycophenolate mofetil Oral Other Name: CellCept, MMF Drug: steroids Oral

Detailed Description:

This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.

Eligibility

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

Criteria

Inclusion Criteria:

Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
Subject is a recipient of a de novo kidney transplant
Subject is a recipient of a kidney from a non-HLA identical related living donor, a non-related living donor, or a deceased donor

Exclusion Criteria:

Subject has a screening (pre-operative)estimated CD4+ T cell count of <250 cells/uL
Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours
Recipient has a positive T or B cell cross match by investigational site's standard method of determination
Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
- History of hypertension and a terminal serum creatinine > 1.5 mg/dl
- Cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dl
- History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543569

Show 38 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:	Senior Medical Director	Astellas Pharma Global Development
Principal Investigator:	Principal Investigator	University of Michigan

More Information

No publications provided

Responsible Party:	Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00543569 History of Changes
Other Study ID Numbers:	0485-CL-U201
Study First Received:	October 11, 2007
Last Updated:	April 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

kidney transplant
alefacept

Additional relevant MeSH terms:

Mycophenolate mofetil
Tacrolimus
Basiliximab
Mycophenolic Acid
Alefacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012