A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00617604
First received: February 6, 2008
Last updated: February 13, 2013
Last verified: September 2010
  Purpose

The purpose of this study is to determine whether alefacept is effective and well tolerated in the prevention of kidney transplant rejection.


Condition Intervention Phase
De Novo Kidney Transplantation
Drug: Alefacept
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Occurence of and time to biopsy proven acute rejection at 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: December 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
IV and subcutaneous
Experimental: Alefacept Drug: Alefacept
IV and subcutaneous

Detailed Description:

Assessment of efficacy and safety of alefacept when used with a combination of tacrolimus, mycophenolate mofetil (MMF) and steroids versus a combination therapy of placebo, tacrolimus and steroids. Effectiveness will be measured as the occurrence of and time to biopsy proven acute rejection.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
  • Male or female subject at least 18 years of age and younger than 65 years
  • Subject receiving a kidney transplant from a non-HLA identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type

Exclusion Criteria:

  • Subject has a PRA grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
  • Subject received a kidney transplant from a non-heart beating donor
  • Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine > 1.5 mg/dL (UNOS expanded criteria donor)
  • Cold ischemia time of the donor kidney is ≥ 30 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617604

  Show 33 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00617604     History of Changes
Other Study ID Numbers: 0485-CL-E201, 2007-002092-14
Study First Received: February 6, 2008
Last Updated: February 13, 2013
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Spain: Ministry of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
kidney transplant
alefacept

Additional relevant MeSH terms:
Mycophenolate mofetil
Alefacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014