Phase 4
Completed N=17
Immune Monitoring to Facilitate Belatacept Monotherapy
Source: ClinicalTrials.gov NCT04177095 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Incidence of Acute Rejection — 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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
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. Informational only — not medical advice.