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A Study of TCD601 in de Novo Renal Transplant Recipients

NCT05669001 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

Conditions

  • Renal Transplantation

Interventions

BIOLOGICAL

TCD601

Investigational Product

BIOLOGICAL

belatacept

Study Product

DRUG

ATG

Comparator

DRUG

TAC

Comparator

DRUG

MPA

Immunosuppression Therapy

DRUG

Corticosteroids

Immunosuppression Therapy

Sponsors & Collaborators

  • ITB-Med LLC

    lead INDUSTRY

Principal Investigators

  • Fredrik Juhlin · ITB-Med LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2026-04-10
Completion
2026-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669001 on ClinicalTrials.gov