NCT04311632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2.4 years

First QC Date

March 12, 2020

Results QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (3)

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

    12 months

  • 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

  • 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 Outcomes (2)

  • The Incidence of Rejection at 12 Months Post-transplant.

    12 months

  • To Assess the Change in Renal Function Over Time.

    12 months

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Biological: TCD601Drug: Tacrolimus (TAC)Drug: Corticosteroids (CS)Drug: Mycophenolate Mofetil (MMF)

Arm 2

EXPERIMENTAL

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

Biological: TCD601Drug: Tacrolimus (TAC)Drug: Corticosteroids (CS)Drug: Mycophenolate Mofetil (MMF)

Arm 3

ACTIVE COMPARATOR

ATG administered with the 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

TCD601BIOLOGICAL

Investigational Product

Arm 1Arm 2
Tacrolimus (TAC)DRUG

Standard of Care Concomitant Immunosuppression

Arm 1Arm 2Arm 3
Corticosteroids (CS)DRUG

Standard of Care Concomitant Immunosuppression

Arm 1Arm 2Arm 3
Mycophenolate Mofetil (MMF)DRUG

Standard of Care Concomitant Immunosuppression

Arm 1Arm 2Arm 3
ATGDRUG

Standard of Care induction therapy in solid organ transplantation

Arm 3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

MeSH Terms

Interventions

TacrolimusAdrenal Cortex HormonesMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Results Point of Contact

Title
Jesse Scott, MPH
Organization
ITB-MED LLC
KTX@itb-med.com
+46 8 410 02 887

Study Officials

  • Nick Hryciw, MA

    ITB-Med LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

March 12, 2020

First Posted

March 17, 2020

Study Start

May 26, 2021

Primary Completion

October 3, 2023

Study Completion

October 3, 2023

Last Updated

February 27, 2025

Results First Posted

February 27, 2025

Record last verified: 2025-02

Locations

US(4)