A Study of TCD601 in de Novo Renal Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ITB-Med LLC
• Treatments: Abatacept; Antilymphocyte Serum; Mycophenolic Acid; Tacrolimus

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 ABO compatable, non-HLA identical living related donor

Key Exclusion Criteria:

• 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