A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)

Phase 2

Recruiting

• Conditions: Kidney Transplantation

• Registration Number: NCT04803006
• Lead Sponsor: ITB-Med LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-3-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Able to understand the study requirements and provide written informed consent<br> before any study assessment is performed<br><br> - Male or female patients = 18 to 65 years of age<br><br> - Recipient of a first renal transplant from a non-HLA identical, but at least<br> haploidentical, ABO compatible living donor<br><br>Key Exclusion Criteria:<br><br> - Women of child-bearing potential, unless willing to comply with the use of highly<br> effective methods of contraception as defined by the protocol<br><br> - A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ<br> of the cervix<br><br> - Recipient with anti-HLA donor-specific antibody (DSA)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome

Secondary Outcome Measures

Name	Time	Method
The incidence of biopsy proven acute rejection, death and graft loss;The incidence of de novo donor-specific antibody