A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients
NCT ID: NCT01163799
Last Updated: 2013-05-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1
Total Enrollment
9 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-07-31
Study Completion Date
2012-08-31
Brief Summary
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The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.
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Detailed Description
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This is a single center, investigator initiated, pilot study to assess the safety and efficacy of Alefacept in combination with Alemtuzumab induction and Myfortic with rapid steroid and calcineurin inhibitor withdrawal in de novo Kidney transplant recipients. Induction therapy involves single dose Alemtuzumab and steroids peri-operatively. Tacrolimus will be administered for the first 30 days post-transplantation. Alefacept will be administered IV for the first two doses followed by subcutaneous injections weekly until 12 weeks post-transplant followed by monthly injections for the rest of the duration of the study. The primary outcomes are safety and efficacy outcomes, including biopsy proven acute rejection episodes, infectious complications or other serious adverse events. Secondary outcomes include T-helper differentiation, cytokine production and T regulatory cell generation assessed by immune monitoring assays.
Conditions
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Transplant; Failure, Kidney
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Alefacept (ASP0485)
Safety and efficacy of alefacept in combination with alemtuzumab induction and calcineurin inhibitor (CNI) and corticosteroid withdrawal.
Group Type
EXPERIMENTAL
Alefacept (ASP0485)
Intervention Type
DRUG
Withdrawal of calcineurin inhibitor at 30 days post-transplant. Administer Alefacept 7.5 mg post-op day 0, post-op day 2 given IV; Alefacept 15 mg SQ X 12 weeks, then monthly until Month 12.
Interventions
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Alefacept (ASP0485)
Withdrawal of calcineurin inhibitor at 30 days post-transplant. Administer Alefacept 7.5 mg post-op day 0, post-op day 2 given IV; Alefacept 15 mg SQ X 12 weeks, then monthly until Month 12.
Intervention Type
DRUG
Other Intervention Names
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ASP0485
Eligibility Criteria
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Inclusion Criteria
* Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization for U.S. sites, or equivalent privacy language as per national regulations, obtained from the subject or legally authorized representative prior to study-related procedures (including withdrawal of prohibited medication, if applicable)
* Recipient of a kidney from a non-HLA identical related living donor, a non- related living donor, or deceased donor
* Recipient of a de novo kidney transplant
* ≥ 18 years of age
* Anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
* Female subjects of child bearing potential must have a negative urine or serum pregnancy test, and must agree to maintain effective birth control during the study
Healthy donor is eligible for the blood draw if:
* Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization for U.S. sites, or equivalent privacy language as per national regulations, is obtained from subject prior to any study-related procedures
* Subject is a donor to a de novo kidney transplant subject who is enrolled in the study or a self declared healthy volunteer who is not a kidney donor for a subject enrolled in the study
* ≥ 18 years of age
* Recipient of a kidney from a non-HLA identical related living donor, a non- related living donor, or deceased donor
* Recipient of a de novo kidney transplant
* ≥ 18 years of age
* Anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
* Female subjects of child bearing potential must have a negative urine or serum pregnancy test, and must agree to maintain effective birth control during the study
Healthy donor is eligible for the blood draw if:
* Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization for U.S. sites, or equivalent privacy language as per national regulations, is obtained from subject prior to any study-related procedures
* Subject is a donor to a de novo kidney transplant subject who is enrolled in the study or a self declared healthy volunteer who is not a kidney donor for a subject enrolled in the study
* ≥ 18 years of age
Exclusion Criteria
* Previously received or is receiving an organ transplant other than a kidney
* Sensitivity to iodine
* Will receive a transplant from a non-heart beating donor (donation after cardiac death - DCD)
* Receives a transplant from an HLA identical related living donor
* Will receive a solitary kidney from a deceased donor \< 5 years of age
* Will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Will receive an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Recipient has a positive T or B cell crossmatch by investigational site's standard method of determination. For recipients where a flow cytometry crossmatch is performed and is positive in either T or B cell testing, recipients are excluded only if donor specific, anti-HLA antibody is detected by flow cytometry based, specific anti-HLA antibody testing.
* Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Significant liver disease
* Serologically negative for cytomegalovirus (CMV) with serologically positive CMV donor
* Serologically negative for Epstein Barr virus
* Has received intravenous immunoglobulin (IVIG) therapy in the three months prior to first dose of study drug
* Uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
* Concurrently participating in another drug study or has received an investigational drug within 28 days prior to transplant
* Known hypersensitivity to alefacept, alemtuzumab, tacrolimus, mycophenolic acid, corticosteroids, or any of their components
* Any form of substance abuse, psychiatric disorder, or a condition that in the opinion of the Investigator could invalidate communication with the Investigator
* Subject is pregnant or lactating
* Subject is unlikely to comply with the visits scheduled in the protocol
* Subject will receive a kidney transplant from an expanded criteria donor (ECD)
* Will receive a kidney transplant from a CDC high risk donor
Healthy donor subject will be excluded from participation if any of the following apply:
* Unable to comprehend the investigational nature of the protocol participation
* Complete blood count results determined to be outside the normal ranges
* Sensitivity to iodine
* Will receive a transplant from a non-heart beating donor (donation after cardiac death - DCD)
* Receives a transplant from an HLA identical related living donor
* Will receive a solitary kidney from a deceased donor \< 5 years of age
* Will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Will receive an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Recipient has a positive T or B cell crossmatch by investigational site's standard method of determination. For recipients where a flow cytometry crossmatch is performed and is positive in either T or B cell testing, recipients are excluded only if donor specific, anti-HLA antibody is detected by flow cytometry based, specific anti-HLA antibody testing.
* Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Significant liver disease
* Serologically negative for cytomegalovirus (CMV) with serologically positive CMV donor
* Serologically negative for Epstein Barr virus
* Has received intravenous immunoglobulin (IVIG) therapy in the three months prior to first dose of study drug
* Uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
* Concurrently participating in another drug study or has received an investigational drug within 28 days prior to transplant
* Known hypersensitivity to alefacept, alemtuzumab, tacrolimus, mycophenolic acid, corticosteroids, or any of their components
* Any form of substance abuse, psychiatric disorder, or a condition that in the opinion of the Investigator could invalidate communication with the Investigator
* Subject is pregnant or lactating
* Subject is unlikely to comply with the visits scheduled in the protocol
* Subject will receive a kidney transplant from an expanded criteria donor (ECD)
* Will receive a kidney transplant from a CDC high risk donor
Healthy donor subject will be excluded from participation if any of the following apply:
* Unable to comprehend the investigational nature of the protocol participation
* Complete blood count results determined to be outside the normal ranges
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Astellas Pharma Inc
INDUSTRY
Sponsor Role
collaborator
Northwestern University
OTHER
Sponsor Role
lead
Responsible Party
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M. Javeed Ansari
Assistant Professor of Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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M. Javeed Ansari, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Universiy, Northwestern Memorial Hospital
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Squifflet JP, Backman L, Claesson K, Dietl KH, Ekberg H, Forsythe JL, Kunzendorf U, Heemann U, Land W, Morales JM, Muhlbacher F, Talbot D, Taube D, Tyden G, van Hooff J, Schleibner S, Vanrenterghem Y; European Tacrolimus-MMF Renal Study Group. Dose optimization of mycophenolate mofetil when administered with a low dose of tacrolimus in cadaveric renal transplant recipients. Transplantation. 2001 Jul 15;72(1):63-9. doi: 10.1097/00007890-200107150-00014.
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Wu Z, Bensinger SJ, Zhang J, Chen C, Yuan X, Huang X, Markmann JF, Kassaee A, Rosengard BR, Hancock WW, Sayegh MH, Turka LA. Homeostatic proliferation is a barrier to transplantation tolerance. Nat Med. 2004 Jan;10(1):87-92. doi: 10.1038/nm965. Epub 2003 Nov 30.
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Yuan X, Ansari MJ, D'Addio F, Paez-Cortez J, Schmitt I, Donnarumma M, Boenisch O, Zhao X, Popoola J, Clarkson MR, Yagita H, Akiba H, Freeman GJ, Iacomini J, Turka LA, Glimcher LH, Sayegh MH. Targeting Tim-1 to overcome resistance to transplantation tolerance mediated by CD8 T17 cells. Proc Natl Acad Sci U S A. 2009 Jun 30;106(26):10734-9. doi: 10.1073/pnas.0812538106. Epub 2009 Jun 15.
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Yuan X, Paez-Cortez J, Schmitt-Knosalla I, D'Addio F, Mfarrej B, Donnarumma M, Habicht A, Clarkson MR, Iacomini J, Glimcher LH, Sayegh MH, Ansari MJ. A novel role of CD4 Th17 cells in mediating cardiac allograft rejection and vasculopathy. J Exp Med. 2008 Dec 22;205(13):3133-44. doi: 10.1084/jem.20081937. Epub 2008 Dec 1.
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Zhai Y, Meng L, Gao F, Busuttil RW, Kupiec-Weglinski JW. Allograft rejection by primed/memory CD8+ T cells is CD154 blockade resistant: therapeutic implications for sensitized transplant recipients. J Immunol. 2002 Oct 15;169(8):4667-73. doi: 10.4049/jimmunol.169.8.4667.
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BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
640 5442000 60026221 01
Identifier Type: OTHER
Identifier Source: secondary_id
STU 00029396
Identifier Type: -
Identifier Source: org_study_id
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