A Dose Escalation Study in de Novo Renal Transplantation

Phase 2

Completed

• Conditions: Kidney Transplantation
• Interventions: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF); Drug: ATG

• Registration Number: NCT04311632
• Lead Sponsor: ITB-Med LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2021-05-26
• Primary Completion: 2023-10-03
• Study Completion: 2023-10-03
• Status Verified: 2025-02
• Results First Submitted: 2025-02-06
• Results First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Results First Posted: 2025-02-27
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	Tacrolimus (TAC)	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 1	Corticosteroids (CS)	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 1	Mycophenolate Mofetil (MMF)	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 2	Tacrolimus (TAC)	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 2	Corticosteroids (CS)	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 2	Mycophenolate Mofetil (MMF)	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 3	Tacrolimus (TAC)	ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 3	Corticosteroids (CS)	ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 3	Mycophenolate Mofetil (MMF)	ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 3	ATG	ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 1	TCD601	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 2	TCD601	TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.	12 months
Measure Peak Plasma Concentration (Cmax) Over Time.	12 months	The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measure the Area Under the Plasma Concentration Versus Time Curve (AUC).	12 months	The AUC from time zero to the last measurable concentration sampling time.

Secondary Outcome Measures

Name	Time	Method
The Incidence of Rejection at 12 Months Post-transplant.	12 months	The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.
To Assess the Change in Renal Function Over Time.	12 months	Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant).

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Saint Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States