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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 first biopsy-confirmed acute rejection (BCAR rate) [ 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 on BCAR by local review) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence of efficacy failure (based on BCAR by central review) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Time to first BCAR as assessed by local review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Maximum grade of acute rejection for patient with BCAR [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence of clinically-treated acute rejections [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Incidence 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 ]
Gastrointestinal Quality of Life Index (GIQLI) symptom severity score and Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
Incidence of new-onset diabetes mellitus after transplantation (NODAT) [ 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 first BCAR, as assessed by central review [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Time to first BCAR, as assessed by central review [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Astellas Pharma Global Development

800-888-7704 x5473

clintrials.info@us.astellas.com

Show 46 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 Trials Registry )
Study ID Numbers:	0485-CL-U201
Study First Received:	October 11, 2007
Last Updated:	December 18, 2009
ClinicalTrials.gov Identifier:	NCT00543569 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

kidney transplant
alefacept

Additional relevant MeSH terms:

Alefacept
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors
Tacrolimus

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Basiliximab
Therapeutic Uses
Mycophenolate mofetil
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010