Kidney TransplantALLTOLNCT02743793
A Cohort Study of Operationally Tolerant Allograft Recipients
An observational study of Kidney Transplant and Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial 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'). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant, Liver Transplant
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2016to 24 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Operationally tolerant recipients of liver or kidney allografts
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University School of Medicine
Atlanta, Georgia, 30324
Ann & Robert H. Lurie Children's Memorial Hospital of Chicago
Chicago, Illinois, 60611
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburg of UPMC
Pittsburgh, Pennsylvania, 15224
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)
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.
Read the detailed description
This is a multi-center, prospective, observational study in which operationally tolerant recipients of liver or kidney allografts will be followed longitudinally, with annual collections of clinical data and biological samples. All participants will be followed for the duration of the study, regardless of changes in their tolerance status.
Participants will be recruited by three main pathways:
- Tolerant participants from current and past Immune Tolerance Network (ITN) trials, including those who have already completed trial participation and those who are anticipated to complete trial participation,
- Tolerant participants referred by ITN affiliated investigators, academic and community transplant physicians and directly through outreach to transplant affinity groups such as the National Kidney Foundation (NKF), and
- Tolerant participants from the general transplant community who are reachable through general contact channels such as the ITN website, word-of-mouth referrals from existing participants, and social media.
- Conditions
- Kidney Transplant, Liver Transplant
- Being tested
- Blood Draw
- Keywords
- single organ liver or kidney allograft, operationally tolerant allograft recipients, longitudinal follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Also called Phlebotomy, Venesection, Venipuncture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Time to development of either:
- de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen; OR
- Donor Specific Antibodies (DSA), a newly developed alloantibody that is against the donor organ.
Alloantibodies are important mediators of acute and chronic rejection.
These data are not yet available.
Measured: 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
Number of participants with acute rejection, steroid resistant rejection and/or chronic rejection.
Criteria employed for acute and chronic rejection: Banff guidelines.
Measured: 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
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.
Measured: Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start30 Jun 2016
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: COVID-19 pandemic and potential risks to study participants and study staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Sindhu Chandran, M.D., Study chair, Immune Tolerance Network (ITN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743793
- Sponsor's protocol ID
- DAIT ITN063ST
- Other IDs
- UM1AI109565
- Acronym
- ALLTOL
- Status last verified
- Aug 2021
- First submitted
- 6 Apr 2016
- Last updated
- 21 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Operationally Tolerant Allograft Recipients (ITN063ST)
- ClinicalTrials.gov ID
- NCT02743793
- Acronym / sponsor ID
- ALLTOL / DAIT ITN063ST
- Conditions
- Kidney Transplant, Liver Transplant
- Keywords
- single organ liver or kidney allograft, operationally tolerant allograft recipients, longitudinal follow-up
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic and potential risks to study participants and study staff.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 21 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, prospective, observational study in which operationally tolerant recipients of liver or kidney allografts will be followed longitudinally, with annual collections of clinical data and biological samples. All participants will be followed for the duration of the study, regardless of changes in their tolerance status.
Participants will be recruited by three main pathways:
- Tolerant participants from current and past Immune Tolerance Network (ITN) trials, including those who have already completed trial participation and those who are anticipated to complete trial participation,
- Tolerant participants referred by ITN affiliated investigators, academic and community transplant physicians and directly through outreach to transplant affinity groups such as the National Kidney Foundation (NKF), and
- Tolerant participants from the general transplant community who are reachable through general contact channels such as the ITN website, word-of-mouth referrals from existing participants, and social media.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operationally Tolerant Kidney or Liver Allograft Recipients | – | Procedure: Blood DrawOperational 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Operationally tolerant recipients of liver or kidney allografts
Key inclusion criteria (10 listed)
- Recipient of single organ liver or kidney allograft from a living or deceased donor;
- At screening, operationally tolerant, as defined by:
- Normal allograft function, defined as:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawAlso: Phlebotomy, Venesection, Venipuncture | Procedure or surgery | Operationally Tolerant Kidney or Liver Allograft Recipients |
Primary outcome
Time to Loss of Operational Tolerance
Time frame: 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 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.
3 secondary outcomes
Time to Development of Anti-Human Leukocyte Antigen (HLA) Antibody or Donor Specific Antibodies (DSA)
Time frame: 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
Time frame: 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
Time frame: Day 0 (Study Enrollment) to Study Completion (Up to 3.7 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- ITN ALLTOL Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sindhu Chandran, M.D. study chair
Immune Tolerance Network (ITN)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant and Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Loss of Operational Tolerance (time frame: From operational tolerance to ITN063ST study completion, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.