Kidney Transplant RejectionPhase 4NCT04177095

Immune Monitoring to Facilitate Belatacept Monotherapy

A Phase 4 study testing Allosure, Immunosuppression reduction and Trugraf in people with Kidney Transplant Rejection and Immunosuppression, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy. To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Transplant Rejection, Immunosuppression
What is being tested?: Allosure, Immunosuppression reduction and Trugraf
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2020to 1 Jun 2023
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age minimum 18 years
Written informed consent
Single kidney transplant recipient (i.e. no combined organ transplants)
Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
At least 1 year after transplantation or after initiation of belatacept
Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)
Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA < 1%; for Trugraf this corresponds to "TX" signature)
No history of BK viremia in current allograft

Who cannot join

History of biopsy-proven acute rejection
Presence of donor-specific antibodies (at any MFI)
Spot urine protein/creatinine ratio > 0.5 g/g

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy.
To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy.

Read the detailed description

This study will examine whether renal transplant recipients treated with a belatacept-based immunosuppressive regimen can safely be weaned off all non-belatacept immunosuppression (mycophenolate, mTORi, prednisone) in a stepwise fashion. To this end, participants will undergo monthly "immune monitoring" using the Allosure (dd-cfDNA) and Trugraf (RNA profiling) blood tests to determine if they are in a state of immune quiescence. Only patients who are deemed to be immune quiescent, will continue to be weaned of non-belatacept immunosuppression.

Conditions: Kidney Transplant Rejection, Immunosuppression
Being tested: Allosure, Immunosuppression reduction, Trugraf

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AllosureDiagnostic test
Also called donor-derived cell-free DNA (dd-cfDNA)
Monthly monitoring of dd-cfDNA levels in blood
Immunosuppression reductionDrug
Also called Belatacept, mycophenolate, sirolimus, everolimus
Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results
TrugrafDiagnostic test
Monthly monitoring of Trugraf result

Study groups in NCT04177095
Study group	Role	What they receive
Belatacept treated patients	Experimental	Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Receives: Diagnostic Test: Allosure; Drug: Immunosuppression reduction; Diagnostic Test: Trugraf

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Acute Rejection
Biopsy-proven according to Banff 2017 criteria
Measured: Enrollment through 12 months
Incidence of Acute Rejection
Biopsy-proven according to Banff 2017 criteria
Measured: Through study completion, 1 year

Secondary outcomes (4)

Increase in eGFR
Calculated using CKD-EPI formula
Measured: From baseline to 12 months
Rate of New-onset Proteinuria
Defined as g/g creatinine, measured on random urine sample
Measured: At 12 months
Incidence of de Novo Donor Specific Antibodies
Screened for using Luminex platform
Measured: At 12 months
Survival
Overall and death-censored graft survival
Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 20201 Jun 2023

First posted26 Nov 2019
Study start11 Feb 2020
Primary completion30 Sep 2021
Study completion1 Jun 2023

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 Transplant RejectionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective single-center, single-arm pilot study
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04177095
Sponsor's protocol ID: 2019P002608
Status last verified: Dec 2023
First submitted: 22 Nov 2019
Last updated: 4 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to share IPD

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant

All Kidney Transplant Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immune Monitoring to Facilitate Belatacept Monotherapy
ClinicalTrials.gov ID: NCT04177095
Acronym / sponsor ID: 2019P002608
Conditions: Kidney Transplant Rejection, Immunosuppression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Transplant Genomics, Inc., CareDx
Study start: 11 Feb 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 26 Nov 2019 (actual)
Results: Posted 4 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy.
To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective single-center, single-arm pilot study

Arm	Type	Receives
Belatacept treated patients	Experimental	Diagnostic Test: Allosure, Drug: Immunosuppression reduction, Diagnostic Test: TrugrafRenal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age minimum 18 years
Written informed consent
Single kidney transplant recipient (i.e. no combined organ transplants)
Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)
At least 1 year after transplantation or after initiation of belatacept

Key exclusion criteria (3 listed)

History of biopsy-proven acute rejection
Presence of donor-specific antibodies (at any MFI)
Spot urine protein/creatinine ratio > 0.5 g/g

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
AllosureAlso: donor-derived cell-free DNA (dd-cfDNA)Monthly monitoring of dd-cfDNA levels in blood	Diagnostic test	Belatacept treated patients
Immunosuppression reductionAlso: Belatacept, mycophenolate, sirolimus, everolimusStepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results	Drug	Belatacept treated patients
TrugrafMonthly monitoring of Trugraf result	Diagnostic test	Belatacept treated patients

Primary outcome

Incidence of Acute Rejection
Time frame: Enrollment through 12 months
Biopsy-proven according to Banff 2017 criteria
Incidence of Acute Rejection
Time frame: Through study completion, 1 year
Biopsy-proven according to Banff 2017 criteria

4 secondary outcomes

Increase in eGFR
Time frame: From baseline to 12 months
Rate of New-onset Proteinuria
Time frame: At 12 months
Incidence of de Novo Donor Specific Antibodies
Time frame: At 12 months
Survival
Time frame: At 12 months

Results and safety

Results posted to the registry on 4 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belatacept Treated Patients	17	10

Primary outcome: Incidence of Acute Rejection

Time frame: Enrollment through 12 months. Count of participants. Unit: Participants

Measure	Belatacept Treated Patients n = 12
Value	0

Primary outcome: Incidence of Acute Rejection

Time frame: Through study completion, 1 year. Count of participants. Unit: Participants

Measure	Belatacept Treated Patients n = 12
Value	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belatacept Treated Patients	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to share IPD

Related trials for Kidney Transplant Rejection

RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant

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.

Hannah Gilligan, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 3 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: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2023). 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?

Incidence of Acute Rejection (time frame: Enrollment through 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04177095.

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 4 Dec 2023.