A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

NCT06365437 | Terminated Phase 2 Results DMC

• 1 other identifier: TCD601B101
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 7

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.

  12 months

• Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.

  The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.

  12 months

• Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).

  The AUC from time zero to the last measurable concentration sampling time.

  12 months

Secondary Outcomes (2)

• The Incidence of Allograft Rejection at 12 Months Post-Transplant

  12 months

• To Assess Renal Function Over Time

  12 months

Study Arms (5)

Arm 1

EXPERIMENTAL

TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)

Arm 2

EXPERIMENTAL

TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)

Arm 3

EXPERIMENTAL

TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)

Arm 4

EXPERIMENTAL

TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)

Arm 5

ACTIVE COMPARATOR

ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).

Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF); Drug: ATG

Interventions

TCD601 BIOLOGICAL

Investigational Product

Also known as: Siplizumab

Arm 1; Arm 2; Arm 3; Arm 4

Tacrolimus (TAC) DRUG

Standard of Care Concomitant Immunosuppression

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

Corticosteroids (CS) DRUG

Standard of Care Concomitant Immunosuppression

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

Mycophenolate Mofetil (MMF) DRUG

Standard of Care Concomitant Immunosuppression

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5

ATG DRUG

Standard of Care induction therapy in solid organ transplantation

Arm 5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ITB-Med LLC: lead

Study Sites (7)

Innsbruck Medical University

Innsbruck, A-6020, Austria

Location

University of Vienna

Vienna, 1090, Austria

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Karolinska University Hospital

Stockholm, Huddinge, 14157, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Skåne University Hospital

Malmo, 20502, Sweden

Location

MeSH Terms

Interventions

siplizumab; Tacrolimus; Adrenal Cortex Hormones; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Jesse Scott
• Organization: ITB-MED LLC

jscott@nefro-avillion.com

623174897

Study Officials

• Fredrik Juhlin

  ITB-Med LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: June 6, 2021
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2025-01

Locations

SE (3); AU (2); ES (2)