Effect of Thymoglobulin Versus Basiliximab on Regulatory T Cell Function in Live Donor Kidney Transplant Recipients

NCT02730715 | Terminated

• 1 other identifier: 811893
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to study the effects that two standard of care immunosuppression induction regimens have on regulatory T cells (Treg) in live donor renal transplant recipients. Both regimens are currently used in this hospital for early immunosuppression induction but the effects on Treg numbers and function is not well understood and likely will impact long term immune function.

Conditions

KIDNEY TRANSPLANTATION

Outcome Measures

Primary Outcomes (2)

• Absolute Treg number Cells

  Each sample will be measured by flow cytometry. Data will be analyzed for each treatment arm using nonparametric statistical tests and expressed as the medium value and inter-quartile range.

  5 years

• Treg function tested by flow cytometry.

  T cells and Tregs will be isolated. T cells will be labeled with CFSE and induced to proliferate by addition of CD3 mAb. Data will be evaluated by nonparametric methods.

  5 years

Secondary Outcomes (1)

• Treg methylation

  5 years

Study Arms (2)

Thymoglobulin

blood specimen collection

Drug: Thymoglobulin

Basiliximab

blood specimen collection

Drug: Basiliximab

Interventions

Basiliximab DRUG

Periodic blood collection to monitor Treg cells

Also known as: Simulect

Basiliximab

Thymoglobulin DRUG

Periodic blood collection to monitor Treg cells

Also known as: Anti-thymocyte globulin

Thymoglobulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Live donor renal transplant recipients

You may qualify if:

• adult patients receiving first live donor kidney transplant. 0-10% panel reactive antibody

You may not qualify if:

• HIV positive, hepatitis C positive, pregnancy, inability to provide informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood urine and renal tissue samples (if available)

MeSH Terms

Interventions

Basiliximab; thymoglobulin; Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immune Sera; Biological Products; Complex Mixtures

Study Officials

• Matthew L Levine, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 6, 2016
• Study Start: November 1, 2010
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

US (1)