- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777400
Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells
A Pilot Trial to Assess the Effect of CNI Conversion to Efalizumab in T Regulatory Cells in Renal Transplantation
Study Overview
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
1 mg/kg of efalizumab administered sub q once weekly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells.
Time Frame: Month 6
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The successful conversion from CNI to non-CNI regimen without increasing the rejection rate by more than 20%.
Time Frame: 6 Months
|
6 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Flavio Vincenti, M.D., University of California, San Francisco
Publications and helpful links
General Publications
- Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
- Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR. The natural history of chronic allograft nephropathy. N Engl J Med. 2003 Dec 11;349(24):2326-33. doi: 10.1056/NEJMoa020009.
- Vincenti F, Mendez R, Pescovitz M, Rajagopalan PR, Wilkinson AH, Butt K, Laskow D, Slakey DP, Lorber MI, Garg JP, Garovoy M. A phase I/II randomized open-label multicenter trial of efalizumab, a humanized anti-CD11a, anti-LFA-1 in renal transplantation. Am J Transplant. 2007 Jul;7(7):1770-7. doi: 10.1111/j.1600-6143.2007.01845.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACD4520 Efalizumab
- ACD4520
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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