A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729768
Recruitment Status : Withdrawn
First Posted : August 7, 2008
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: basiliximab Drug: efalizumab Drug: mycophenolate mofetil Drug: corticosteroids Drug: cyclosporine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: basiliximab
2 intravenous doses

Drug: efalizumab
Subcutaneous repeating dose

Drug: mycophenolate mofetil
Oral repeating dose

Drug: corticosteroids
Repeating doses

Active Comparator: 2 Drug: basiliximab
2 intravenous doses

Drug: mycophenolate mofetil
Oral repeating dose

Drug: corticosteroids
Repeating doses

Drug: cyclosporine
Oral repeating dose

Primary Outcome Measures :
  1. Subject and renal allograft survival [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 12 and 52 weeks ]
  2. Change in glomerular filtration rate [ Time Frame: 12 weeks to 52 weeks ]
  3. Transplant renal biopsies [ Time Frame: 52 weeks ]
  4. Change in metabolic/cardiovascular risk factors [ Time Frame: 24 weeks and 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Have signed the informed consent form and the HIPAA patient information form (United States only)
  • Are ≥ 18 years of age
  • Are a transplant recipient of at least one HLA-mismatch kidney
  • For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method

Key Exclusion Criteria:

  • Have a history of previous renal transplant
  • Have had a PRA > 25% at any time
  • Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
  • Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
  • Have had previous treatment with efalizumab
  • Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
  • Have a known contraindication to efalizumab
  • Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
  • Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
  • Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729768

Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT00729768     History of Changes
Other Study ID Numbers: ACD4230g
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: March 2009

Keywords provided by Genentech, Inc.:
Renal transplant

Additional relevant MeSH terms:
Mycophenolic Acid
Immunosuppressive Agents
Antibodies, Monoclonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents