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

Phase 2

Withdrawn

• Conditions: Kidney Transplantation
• Interventions: Drug: basiliximab; Drug: efalizumab; Drug: mycophenolate mofetil; Drug: corticosteroids; Drug: cyclosporine

• Registration Number: NCT00729768
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-02
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-07
• Status Verified: 2009-03
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	basiliximab	-
1	corticosteroids	-
2	corticosteroids	-
1	efalizumab	-
1	mycophenolate mofetil	-
2	mycophenolate mofetil	-
2	cyclosporine	-
2	basiliximab	-

Primary Outcome Measures

Name	Time	Method
Subject and renal allograft survival	52 weeks

Secondary Outcome Measures

Name	Time	Method
Glomerular filtration rate	12 and 52 weeks
Change in glomerular filtration rate	12 weeks to 52 weeks
Transplant renal biopsies	52 weeks
Change in metabolic/cardiovascular risk factors	24 weeks and 52 weeks