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

NCT01163799 | Terminated Phase 1 DMC

• 2 other identifiers: STU 00029396640 5442000 60026221 01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess Alefacept in combination with alemtuzumab induction and calcineurin inhibitor and corticosteroid withdrawal.

Conditions

Transplant; Failure, Kidney

Keywords

Kidney; Transplant; Northwestern; Calcineurin Inhibitor; Corticosteroids; Steroid avoidance

Outcome Measures

Primary Outcomes (1)

• Incidence of first biopsy- proven acute rejection (Banff Grade≥ 1) (BCAR rate) and infections

  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 Outcomes (2)

• Affect on Immune cells

  Up to 12 months post-transplant

• Assess secondary outcome measures of efficacy and safety

  Upto 12 months post-transplant

Study Arms (1)

Alefacept (ASP0485)

EXPERIMENTAL

Safety and efficacy of alefacept in combination with alemtuzumab induction and calcineurin inhibitor (CNI) and corticosteroid withdrawal.

Drug: Alefacept (ASP0485)

Interventions

Alefacept (ASP0485) 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.

Also known as: ASP0485

Alefacept (ASP0485)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (60)

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MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• M. Javeed Ansari, MD

  Northwestern Universiy, Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: August 1, 2012
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)