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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00729768
• Other study ID #: ACD4230g
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: August 2, 2008
• Last updated: June 21, 2017

Study information

• Verified date: March 2009
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• basiliximab
2 intravenous doses
• efalizumab
Subcutaneous repeating dose
• mycophenolate mofetil
Oral repeating dose
• corticosteroids
Repeating doses
• cyclosporine
Oral repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject and renal allograft survival		52 weeks
Secondary	Glomerular filtration rate		12 and 52 weeks
Secondary	Change in glomerular filtration rate		12 weeks to 52 weeks
Secondary	Transplant renal biopsies		52 weeks
Secondary	Change in metabolic/cardiovascular risk factors		24 weeks and 52 weeks