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Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777400
Recruitment Status : Withdrawn (New safety information reported in the post-marketing setting with efalizumab for treatment of chronic plaque psoriasis and trial conduct feasibility issues.)
First Posted : October 22, 2008
Last Update Posted : May 14, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Drug: Efalizumab Phase 1 Phase 2

Detailed Description:

The objective of this pilot trial is to determine whether the conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to efalizumab and sirolimus is associated with an increase in T regulatory cells and does not result in an increase in acute rejection following conversion. CNIs are associated with progressive nephrotoxicity, increased cardiovascular risk factor as well as an inhibitory effect on T regulatory cells.

PRIMARY OBJECTIVE:

To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells. A hundred percent increase in T regulatory cells will be determined to be an important biologic effect of the combination of efalizumab and sirolimus.

SECONDARY OBJECTIVES:

To assess the feasibility of the conversion from CNI/MMF to efalizumab/sirolimus and to determine that this combination is safe and effective

To determine if there is an increase in FoxP3 mRNA in the urine of converted patients. Urine FoxP3 is believed to correlate with T regs in the kidney.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Pilot Trial to Assess the Effect of CNI Conversion to Efalizumab in T Regulatory Cells in Renal Transplantation
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Efalizumab will be started on Day 0 until the end of the study at Week 24. At the end of the first week, after efalizumab is started, cyclosporine or tacrolimus will be decreased by 50% and at 2 weeks the dose of cyclosporine or tacrolimus will be completely discontinued. At 12 weeks Cellcept or myfortic will be discontinued and the patient will be converted to sirolimus for the remainder of the study.
Drug: Efalizumab
1 mg/kg of efalizumab administered sub q once weekly




Primary Outcome Measures :
  1. To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells. [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. The successful conversion from CNI to non-CNI regimen without increasing the rejection rate by more than 20%. [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Male or female, 18-70 years
  • Recipients of primary renal transplants from living and deceased donors
  • Stable renal function for 4 weeks prior to entry into the study
  • No history of acute rejection
  • Pretransplant negative crossmatch
  • Hematocrit >30% at the time of inclusion, platelet count >100,000 and WBC ≥ 3.0
  • If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
  • If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.

Exclusion Criteria:

  • Patients with known hypersensitivity to Raptiva® (efalizumab) or any of its components.
  • Pregnant or lactating women
  • Pretransplant PRA >20%
  • cGFR < 35/ml/min
  • >500 mg protein as estimated by spot protein/creatinine ratio
  • Recipients of other organ transplants
  • Subject has a current malignancy or a history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
  • Patients receiving experimental immunosuppressive agents
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777400


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
Investigators
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Principal Investigator: Flavio Vincenti, M.D. University of California, San Francisco
Publications of Results:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00777400    
Other Study ID Numbers: ACD4520 Efalizumab
ACD4520
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by University of California, San Francisco:
Kidney transplant
T regulatory cells
Efalizumab
Rejection
Safely convert renal transplant from mycophenolate mofetil and Calcineurin inhibitor to efalizumab and sirolimus
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases