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ACTIVE NOT RECRUITING Phase 2

A Study of TCD601 in de Novo Renal Transplant Recipients

NCT05669001 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG ATG
  • BIOLOGICAL belatacept
  • BIOLOGICAL TCD601
  • DRUG TAC
  • DRUG MPA

Study Locations (17)

California

  • University of California Davis Medical Center — Sacramento
  • University of California San Francisco Medical Center — San Francisco

Illinois

  • Northwestern University — Chicago
  • Loyola University Medical Center — Maywood

Virginia

  • University of Virginia Health — Charlottesville
  • Inova Fairfax Hospital Medical Campus — Falls Church

Florida

  • Tampa General Hospital — Tampa

Georgia

  • Emory University Hospital — Atlanta

Louisiana

  • Ochsner Clinic Foundation — New Orleans

Massachusetts

  • Massachusetts General Hospital — Boston

Michigan

  • Henry Ford Hospital — Detroit

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2023-12-28
Est. Completion 2026-04
Phase Phase 2

Sponsor

ITB-Med

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05669001

The ClinicalTrials.gov registry entry for NCT05669001 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ITB-Med, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Renal Transplantation appearing as the primary indexed condition, and to 5 interventions — of which ATG is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05669001 reports 17 study locations spanning 14 distinct geographic areas — top geographies include California, Illinois, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05669001 about?

NCT05669001 is a clinical study titled "A Study of TCD601 in de Novo Renal Transplant Recipients". 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.

What is the current status of trial NCT05669001?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2023-12-28. Estimated completion is 2026-04.

What conditions does trial NCT05669001 study?

This clinical trial studies the following conditions: Renal Transplantation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05669001?

The interventions under investigation include: ATG (DRUG), belatacept (BIOLOGICAL), TCD601 (BIOLOGICAL), TAC (DRUG), MPA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05669001?

This trial is sponsored by ITB-Med, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05669001 being conducted?

This trial has 17 study locations across California, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial