Kidney Transplantation
Conditions
Brief summary
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
Interventions
BIOLOGICALTCD601
Investigational Product
Sponsors
ITB-Med LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand the study requirements and provide written informed consent before any study assessment is performed * Male or female patients ≥ 18 to 65 years of age * Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor Key
Exclusion criteria
* Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol * A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix * Recipient with anti-HLA donor-specific antibody (DSA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance | 24 months | The proportion of patients off immunosuppression with good safety and tolerability |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biopsy proven acute rejection, death, and graft loss | 24 months |
| The incidence of DSA | 24 months |
Countries
South Korea, United States
Contacts
STUDY_DIRECTORTracy Killingsworth
Nefro Avillion
Outcome results
None listed