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

June 21, 2017 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: basiliximab
2 intravenous doses
Drug: mycophenolate mofetil
Oral repeating dose
Drug: corticosteroids
Repeating doses
Drug: cyclosporine
Oral repeating dose
EXPERIMENTAL: 1
Drug: basiliximab
2 intravenous doses
Drug: efalizumab
Subcutaneous repeating dose
Drug: mycophenolate mofetil
Oral repeating dose
Drug: corticosteroids
Repeating doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subject and renal allograft survival
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Glomerular filtration rate
Time Frame: 12 and 52 weeks
12 and 52 weeks
Change in glomerular filtration rate
Time Frame: 12 weeks to 52 weeks
12 weeks to 52 weeks
Transplant renal biopsies
Time Frame: 52 weeks
52 weeks
Change in metabolic/cardiovascular risk factors
Time Frame: 24 weeks and 52 weeks
24 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 2, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (ESTIMATE)

August 7, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACD4230g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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