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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00729768
First received: August 2, 2008
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Kidney Transplantation
Drug: basiliximab
Drug: efalizumab
Drug: mycophenolate mofetil
Drug: corticosteroids
Drug: cyclosporine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Subject and renal allograft survival [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glomerular filtration rate [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Change in glomerular filtration rate [ Time Frame: 12 weeks to 52 weeks ] [ Designated as safety issue: No ]
  • Transplant renal biopsies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in metabolic/cardiovascular risk factors [ Time Frame: 24 weeks and 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00729768

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Jay Garg, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00729768     History of Changes
Other Study ID Numbers: ACD4230g
Study First Received: August 2, 2008
Last Updated: March 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Renal transplant
Raptiva

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Immunosuppressive Agents
Mycophenolate mofetil
Mycophenolic Acid
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014