Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

NCT01213329 | Terminated Phase 4 Results

• 1 other identifier: STU00011048
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.

  Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months \& 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells \& NK cells, naive \& memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). Unfortunately blood samples were lost due to malfunction of liquid nitrogen tank that stopped working during a power loss.

  Pre-transplant, 6months & 12 months post-transplant

Secondary Outcomes (1)

• Donor Specific Hypo-reactivity.

  Pre-transplant, 6mo & 12mo post-transplant

Study Arms (1)

Phase I: Alemtuzumab

EXPERIMENTAL

During Phase I Portion: Each kidney transplant recipient received one 30mg dose (IV push)of Alemtuzmab in the operating room per Standard of Care.

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.

Also known as: Campath 1-H®

Phase I: Alemtuzumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects between ages 18-65 years old of either gender
• Recipients have an available ABO compatible living donor for transplant
• Subjects are listed to be a single-organ transplant recipient (kidney only)
• Subjects have the ability to provide informed consent

You may not qualify if:

• Subjects have panel reactive antibody greater than 35%
• Subjects have the potential to have a high recurrence rate of their primary renal disease (i.e. Focal Segmental Glomerulonephritis )
• Subjects who have a history of Hepatitis C
• Subjects who have had a previous organ transplant
• Subjects are unable to fully understand the purpose of the study, thereby unable to give a fully informed consent
• Subjects with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
• Subjects who are pregnant or nursing
• Subjects who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.

Sponsors & Collaborators

• Northwestern University: lead
• American Society of Transplant Surgeons: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Alemtuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Processing of blood samples was inconsistent and lab results were questionable. Research blood specimens were in addition to Standard of Care (SOC) required blood. Most research visits were planned at the same time as SOC visits.

Results Point of Contact

• Title: Dr. Lorenzo Gallon
• Organization: Northwestern University

l-gallon@northwestern.edu

312-695-8900

Study Officials

• Lorenzo Gallon, MD

  Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine & Surgery

Model Details: Phase 1: 50 subjects were to receive study intervention. If any subjects demonstrated persistent donor specific unresponsiveness at the 12 month post-transplant time point, they would proceed into Phase 2. In that phase, the unresponsive subjects would have been randomized to one of three arms that would modify their standard of care immunosuppression. None of the 50 subjects from Phase 1 demonstrated persistent donor specific unresponsiveness, therefore, phase 2 was never started.

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: February 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 10, 2019
• Results First Posted: July 4, 2011

Record last verified: 2019-03

Locations

US (1)