A Dose Escalation Study in de Novo Renal Transplantation

Kidney Transplantation Clinical Trial

Official title:

A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311632
• Other study ID #: TCD601B102
• Status: Completed
• Phase: Phase 2
• Start date: May 26, 2021
• Est. completion date: October 3, 2023

Study information

• Verified date: April 2024
• Source: ITB-Med LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Biological:
• TCD601
Investigational Product

Drug:
• Tacrolimus (TAC)
Standard of Care Concomitant Immunosuppression
• Corticosteroids (CS)
Standard of Care Concomitant Immunosuppression
• Mycophenolate Mofetil (MMF)
Standard of Care Concomitant Immunosuppression
• ATG
Standard of Care induction therapy in solid organ transplantation

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Saint Barnabas Medical Center	Livingston	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
ITB-Med LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.		12 months
Primary	Measure Peak Plasma Concentration (Cmax) over time.	The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.	12 months
Primary	Measure the Area under the plasma concentration versus time curve (AUC).	The AUC from time zero to the last measurable concentration sampling time.	12 months
Secondary	Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time.		12 months
Secondary	Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time.		12 months
Secondary	Measure peripheral CD2-receptor occupancy following TCD601 administration	Receptor Occupancy will be reported as the % of target saturation.	12 months