A Cohort Study of Operationally Tolerant Allograft Recipients

NCT02743793 | Terminated Results DMC

• 2 other identifiers: DAIT ITN063STUM1AI109565
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 5

Brief Summary

Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Some organ transplant recipients can stop taking anti-rejection medicines without rejecting their transplanted organ (this is called 'tolerance'). The purpose of this study will collect samples and data from 'tolerant' liver or kidney transplant recipients in order to find out: The purpose of this study is to collect samples and data in order to find out:

• How long liver or kidney transplant recipients can remain tolerant;
• What happens in the tolerant recipient's body over time; and
• If there are patterns in the body that are linked to tolerance.

Conditions

Kidney Transplant; Liver Transplant

Keywords

single organ liver or kidney allograft; operationally tolerant allograft recipients; longitudinal follow-up

Outcome Measures

Primary Outcomes (1)

• Time to Loss of Operational Tolerance

  A participant is considered to have operational tolerance if they are off all immunosuppression medication while continuing to have stable allograft function and no rejection. For these participants, the date of operational tolerance is considered as 52 weeks from the participant's last documented dose of immunosuppression. A participant will be considered to have lost operational tolerance if they experience rejection, have loss of stable allograft function (in the absence of confounding factors), or restart immunosuppression. The endpoint was analyzed using Kaplan-Meier survival estimate and associated two-sided 95% confidence interval, using a delayed-entry model with left-truncation of survival times by censoring the time from achieving operational tolerance at the time of study enrollment. The survival estimate is at the time of the last of event.

  From operational tolerance to ITN063ST study completion, assessed up to 60 months

Secondary Outcomes (3)

• Time to Development of Anti-Human Leukocyte Antigen (HLA) Antibody or Donor Specific Antibodies (DSA)

  Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)

• Number of Participants With Biopsy-Proven or Clinical Acute Rejection, Steroid Resistant Rejection and/or Chronic Rejection

  Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)

• Number of Participants With Graft Loss, Not Including Death With a Functioning Graft

  Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)

Study Arms (1)

Operationally Tolerant Kidney or Liver Allograft Recipients

Operational tolerance at baseline is defined as: * An absence of any immunosuppressive therapy for ≥ 52 weeks prior to the screening visit; * No evidence of allograft rejection in the 52 weeks prior to the screening visit (Day 0), based on the participant's medical history; and * Normal and stable allograft function at screening visit defined as- * For liver transplant recipients: Liver function tests (ALT, GGT) both less than or equal to the upper limit of normal (ULN) * For kidney transplant recipients: Serum creatinine value corresponds to an estimated glomerular filtration rate (GFR) \> 45 ml/min/1.73 m\^2.

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

Also known as: Phlebotomy, Venesection, Venipuncture

Operationally Tolerant Kidney or Liver Allograft Recipients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Operationally tolerant recipients of liver or kidney allografts

You may qualify if:

• Recipient of single organ liver or kidney allograft from a living or deceased donor;
• At screening, operationally tolerant, as defined by:
• Absence of any immunosuppressive therapy for ≥52 weeks prior to the screening visit, and
• No evidence of allograft rejection in the 52 weeks prior to the screening visit, based on the allograft recipient's medical history.
• Normal allograft function, defined as:
• For liver transplant recipients: Liver function tests (ALT, GGT) both less than or equal to the upper limit of normal (ULN); and,
• For kidney transplant recipients: Serum creatinine value corresponds to an estimated GFR \> 45 ml/min/1.73 m\^2.
• Receiving regular follow-up for a kidney or liver transplant by a local physician:
• Participants must be willing to allow the study team to contact and share medical information with this local physician.
• Ability to sign informed consent.

You may not qualify if:

• Current malignancy requiring recent surgery, ongoing chemotherapy, or radiation;
• Transplant of another organ;
• Current drug or alcohol dependency;
• Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; and
• Inability to comply with the study visit schedule and required assessments.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator
• PPD Development, LP: collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30324, United States

Location

Ann & Robert H. Lurie Children's Memorial Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburg of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Immune Tolerance Network (ITN)
• ITN ALLTOL Study website

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Interventions

Blood Specimen Collection; Phlebotomy

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutics

Limitations and Caveats

The study team ended the study early due to the COVID-19 pandemic on March 24, 2020.

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

13015947669

Study Officials

• Sindhu Chandran, M.D.

  Immune Tolerance Network (ITN)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 19, 2016
• Study Start: June 30, 2016
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: September 21, 2021
• Results First Posted: September 21, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

US (5)