Phase 2
Completed N=24
Treg Modulation With CD28 and IL-6 Receptor Antagonists
Living-Donor Kidney Transplant · kidney transplant recipients
Source: ClinicalTrials.gov NCT04066114 ↗
Enrolled (actual)
24
Serious AEs
47.1%
Results posted
Oct 2024
Primary outcomePrimary: The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 6 Months Post-transplantation. — 0.500 Proportion of participants
Summary
The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 6 Months Post-transplantation. |
0.500 | — |
| SECONDARY The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 12 Months Post-transplantation. |
0.500 | — |
Eligibility Criteria
Inclusion Criteria
Individuals who meet all the following criteria are eligible for enrollment as study participants:
- Able to understand and provide informed consent
- Agreement to use highly effective ( 350 mg/dL, LDL >190 mg/dL, or triglycerides >500 mg/dL)
- Transaminase levels elevated more than 1.5 times the upper limit of normal (ULN) within 7 days prior to enrollment
- The absolute neutrophil count (ANC) < 2,000 per mm^3 within 7 days prior to enrollment
- Platelet count less than 100, 000 per mm^3 within 7 days prior to enrollment
- More than 50% CD8+/ CD28- T-cells in peripheral blood
- A calculated panel reactive antibody (cPRA) ≥20%, as determined by each participating site's laboratory
- Positive pregnancy test in women of child bearing potential, currently breastfeeding, or planning to become pregnant during the timeframe of the study or follow-up period
- Participation in any other studies with investigational drugs or regimens in the preceding year
Data sourced from ClinicalTrials.gov (NCT04066114). 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.