A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

May 1, 2013 updated by: M. Javeed Ansari, Northwestern University
The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alefacept (ASP0485)
Safety and efficacy of alefacept in combination with alemtuzumab induction and calcineurin inhibitor (CNI) and corticosteroid withdrawal.
Drug: 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.
Other Names:
  • ASP0485

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of first biopsy- proven acute rejection (Banff Grade≥ 1) (BCAR rate) and infections
Time Frame: At 12 months post-transplant
To assess the safety and efficacy of alefacept in combination with a single dose of alemtuzamab induction and Enteric coated Mycophenolic sodium with calcineurin inhibitor withdrawal and rapid elimination of corticosteroids by examining the incidence of first biopsy-proven acute rejection (Banff Grade≥ 1) (BCAR rate) and the incidence and clinical presentation of infections.
At 12 months post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affect on Immune cells
Time Frame: Up to 12 months post-transplant
To assess how alefacept affects T-cell differentiation, memory, and immunoregulatory T-cell homeostasis, B-cells and cytokine/chemokine profile by using various immune monitoring assays.
Up to 12 months post-transplant
Assess secondary outcome measures of efficacy and safety
Time Frame: Upto 12 months post-transplant
At 12 months: Patient/graft survival rates, BCAR rate, Maximum grade of acute rejection with BCAR, Incidence of clinically-treated acute rejections, Incidence of anti-lymphocyte antibody therapy for treatment of rejection, Incidence of multiple rejection episodes, Incidence of treatment failure (defined as death, graft loss, biopsy-confirmed acute rejection, lost to follow-up or early discontinuation of treatment regimen), Incidence of leucopenia, Incidence of bacterial, fungal, viral, or parasitic infection. At 6 & 12 months: Serum creatinine, GFR by iohexol clearance. Time to first BCAR
Upto 12 months post-transplant

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: M. Javeed Ansari, MD, Northwestern Universiy, Northwestern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 00029396
  • 640 5442000 60026221 01 (Other Identifier: Northwestern University Internal Tracking Number)

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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