Status:
COMPLETED
A Dose Escalation Study in de Novo Renal Transplantation
Lead Sponsor:
ITB-Med LLC
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04311632
Start Date
May 26 2021
End Date
October 3 2023
Last Update
February 27 2025
Active Locations (4)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039