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

NCT00729768 | Withdrawn Phase 2

• 1 other identifier: ACD4230g
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplantation

Keywords

Renal transplant; Raptiva

Outcome Measures

Primary Outcomes (1)

• Subject and renal allograft survival

  52 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: basiliximab; Drug: efalizumab; Drug: mycophenolate mofetil; Drug: corticosteroids

2

ACTIVE COMPARATOR

Drug: basiliximab; Drug: mycophenolate mofetil; Drug: corticosteroids; Drug: cyclosporine

Interventions

basiliximab DRUG

2 intravenous doses

1; 2

efalizumab DRUG

Subcutaneous repeating dose

1

mycophenolate mofetil DRUG

Oral repeating dose

1; 2

corticosteroids DRUG

Repeating doses

1; 2

cyclosporine DRUG

Oral repeating dose

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

Basiliximab; efalizumab; Mycophenolic Acid; Adrenal Cortex Hormones; Cyclosporine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2008
• First Posted: August 7, 2008
• Last Updated: June 22, 2017

Record last verified: 2009-03