NCT02743793: ALLTOL

A Cohort Study of Operationally Tolerant Allograft Recipients

Terminated Results posted Last updated 21 September 2021

What this trial tests

trial testing Blood Draw in Kidney Transplant in 41 participants. Terminated before completion.

Timeline

30 June 2016

Primary endpoint
24 March 2020

24 March 2020

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	41
Start date	30 June 2016
Primary completion	24 March 2020
Estimated completion	24 March 2020
Sites	5 locations across United States

Drugs / interventions tested

• Blood Draw — full drug profile →

Conditions studied

• Kidney Transplant — all drugs for Kidney Transplant →
• Liver Transplant — all drugs for Liver Transplant →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Eligibility, any sex, with Kidney Transplant or Liver Transplant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Loss of Operational Tolerance Primary · From operational tolerance to ITN063ST study completion, assessed up to 60 months

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

Group	Value	95% CI
Accrued	6.6	± 5.38

Number of Participants With Biopsy-Proven or Clinical Acute Rejection, Steroid Resistant Rejection and/or Chronic Rejection Secondary · Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)

Number of participants with acute rejection, steroid resistant rejection and/or chronic rejection. Criteria employed for acute and chronic rejection: Banff guidelines.

Group	Value	95% CI
Accrued	0

Number of Participants With Graft Loss, Not Including Death With a Functioning Graft Secondary · Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)

A participant is considered to have graft loss when the participant is retransplanted with another donor kidney, relisted for transplantation, or dies with a non-functioning graft.

Group	Value	95% CI
Accrued	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.