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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00729768

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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 Design

Study Type:

Interventional

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

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Subject and renal allograft survival [52 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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