Phase 2
N=13
A Dose Escalation Study in de Novo Renal Transplantation
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT04311632 ↗Enrolled (actual)
13
Serious AEs
61.5%
Results posted
Feb 2025
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. — 2; 4; 7; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TCD601 (Biological); Tacrolimus (TAC) (Drug); Corticosteroids (CS) (Drug); Mycophenolate Mofetil (MMF) (Drug); ATG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ITB-Med LLC
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. |
2; 4; 7; 0; 0; 0 | — |
| PRIMARY Measure Peak Plasma Concentration (Cmax) Over Time. |
5.0; 17.5 | — |
| PRIMARY Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). |
23.0; 162.0 | — |
| SECONDARY The Incidence of Rejection at 12 Months Post-transplant. |
1; 0; 1; 1; 4; 6 | — |
| SECONDARY To Assess the Change in Renal Function Over Time. |
40.4; 50.2; 45.9; 40.5; 48.2; 48.2 | — |
Summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Eligibility Criteria
Key Inclusion Criteria
- Able to understand the study requirements and provide written informed consent before and study assessment is performed.
- Male or female patients ≥ 18 to 70 years of age.
- Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor.
- Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.
Key Exclusion Criteria
- Multiple-organ transplant recipients
- Subjects who have received a kidney allograft previously
- Recipient of a kidney from an HLA identical living related donor
- Recipient of a kidney from a donor after cardiac death
- Subjects at high immunological risk for rejection
Data sourced from ClinicalTrials.gov (NCT04311632). 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.