Expired Study
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San Francisco, California 94143


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

ACD4520 Efalizumab


NCT ID:

NCT00777400


Secondary ID:

ACD4520


Study Acronym:


Brief Title:

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


Official Title:

A Pilot Trial to Assess the Effect of CNI Conversion to Efalizumab in T Regulatory Cells in Renal Transplantation


Overall Status:

Withdrawn


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

New safety information reported in the post-


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Flavio Vincenti, M.D.
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:December 2008
Completion Date:April 2009
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 13, 2013
First Received Date:October 20, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The successful conversion from CNI to non-CNI regimen without increasing the rejection rate by more than 20%.
Time Frame:6 Months
Safety Issues:True
Outcome Type:Primary Outcome
Measure:To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells.
Time Frame:Month 6
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Efalizumab
Description:1 mg/kg of efalizumab administered sub q once weekly
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:14668458
Reference Type:Results Reference
Citation: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.
PMID:14961990
Reference Type:Results Reference
Citation: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.
PMID:17564637

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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