Phase 4 N=17 Diagnostic

Immune Monitoring to Facilitate Belatacept Monotherapy

Kidney Transplant Rejection · Immunosuppression

Bottom Line

View on ClinicalTrials.gov: NCT04177095 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Incidence of Acute Rejection — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Allosure (Diagnostic_test); Immunosuppression reduction (Drug); Trugraf (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Acute Rejection	—	—
PRIMARY Incidence of Acute Rejection	—	—
SECONDARY Increase in eGFR	6	—
SECONDARY Rate of New-onset Proteinuria	1	—
SECONDARY Incidence of de Novo Donor Specific Antibodies	—	—
SECONDARY Survival	12	—

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.

Eligibility Criteria

Inclusion Criteria

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 0.5 g/g

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04177095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.