Associating Renal Transplantation With the ITN Signature of Tolerance

NCT01516177 | Completed DMC

• 1 other identifier: DAIT ITN524ST/CTOT-12
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

Brief Summary

This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression. The study goal is to find out how common this pattern is in transplant patients, as a first step in determining if it can be used to personalize anti-rejection drug regimens better.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; kidney transplant; renal transplant; immunosuppression

Outcome Measures

Primary Outcomes (1)

• The presence of at least one time point of the previously identified renal transplant tolerance signature.

  2 years

Secondary Outcomes (4)

• Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.

  2 years

• Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments

  2 years

• Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype

  2 years

• Selected clinical events and laboratory parameters to assess hematologic and renal function

  2 years

Study Arms (1)

Renal Transplant Recipients

Subjects who received a kidney transplant within the past 1 to 5 years

Eligibility Criteria

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

Study Population

The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria. Among those eligible for further follow-up * at least 25 participants will be renal transplant recipients who received induction therapy with Campath, and * at least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment

You may qualify if:

• Received first kidney transplant from a living or deceased donor.
• Kidney transplanted between 1 and 5 years ago.
• Calculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months
• Ability to understand and provide informed consent.

You may not qualify if:

• History of steroid-resistant acute rejection
• History of two or more episodes of acute rejection
• Any acute rejection in the past year
• Current malignancy
• Transplant of another organ
• AIDS according to the CDC definition of AIDS.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator
• Clinical Trials in Organ Transplantation: collaborator

Study Sites (8)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Newell KA, Asare A, Kirk AD, Gisler TD, Bourcier K, Suthanthiran M, Burlingham WJ, Marks WH, Sanz I, Lechler RI, Hernandez-Fuentes MP, Turka LA, Seyfert-Margolis VL; Immune Tolerance Network ST507 Study Group. Identification of a B cell signature associated with renal transplant tolerance in humans. J Clin Invest. 2010 Jun;120(6):1836-47. doi: 10.1172/JCI39933. Epub 2010 May 24.

  PMID: 20501946 BACKGROUND

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) website
• Immune Tolerance Network website
• Clinical Trials in Organ Transplantation website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Isolation PBMC isolated RNA specimens

Study Officials

• Anil Chandraker, MD

  Brigham and Women's Hospital

  STUDY CHAIR

• Kenneth Newell, MD, PhD

  Emory University

  STUDY CHAIR

• Laurence Turka, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

US (8)