Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

NCT ID: NCT01213329

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-04-30

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.

Detailed Description

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. We will look for these cells using a number of laboratory tests; It will require the subjects to each give 65mL of blood at each of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to participate in phase 2 depending on lab results.

In phase 2, subjects will be randomized to one of the three following groups:

Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)

Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be continued at the same dosage.

Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued at the same dosage.

There will be an analysis of these cells at different time point, pre and post kidney transplant. The data collection will allow us to study the stability over time of particular phenotypes (cell structures) and T cell function. We will also evaluate how the two different "minimizing protocols" effect the cell structure. Results from laboratory testing may allow us to define certain criteria that can be broadly applied in solid organ transplant recipients. This may allow for safe reduction of the anti-rejection medication that transplant recipients receive.

Conditions

Kidney Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I: Alemtuzumab

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

Group Type: EXPERIMENTAL

Alemtuzumab

Intervention Type: DRUG

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

Interventions

Alemtuzumab

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

Intervention Type: DRUG

Other Intervention Names

Campath 1-H®

Eligibility Criteria

Inclusion Criteria

1. Adult subjects between ages 18-65 years old of either gender

2. Recipients have an available ABO compatible living donor for transplant

3. Subjects are listed to be a single-organ transplant recipient (kidney only)

4. Subjects have the ability to provide informed consent

Exclusion Criteria

1. Subjects have panel reactive antibody greater than 35%

2. Subjects have the potential to have a high recurrence rate of their primary renal disease (i.e. Focal Segmental Glomerulonephritis )

3. Subjects who have a history of Hepatitis C

4. Subjects who have had a previous organ transplant

5. Subjects are unable to fully understand the purpose of the study, thereby unable to give a fully informed consent

6. Subjects with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum

7. Subjects who are pregnant or nursing

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Transplant Surgeons

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Gallon

Associate Professor of Medicine & Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Gallon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00011048

Identifier Type: -

Identifier Source: org_study_id