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NCT04311632 · ClinicalTrials.gov registry record · Phase 2

A Dose Escalation Study in de Novo Renal Transplantation

A Phase 2 study, sponsored by ITB-Med.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target

NCT04311632 is a Phase 2 study that has completed, run by ITB-Med. The registered enrollment target is 13 participants.

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The verdict

NCT04311632, a Phase 2 study, has completed, sponsored by ITB-Med.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study 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.

Interventions

  • DRUG ATG
  • DRUG Mycophenolate Mofetil (MMF)
  • BIOLOGICAL TCD601
  • DRUG Corticosteroids (CS)
  • DRUG Tacrolimus (TAC)

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-05-26
Est. Completion 2023-10-03
Phase Phase 2

Sponsor

ITB-Med

4 total trials

What the Registry Record Tells You About NCT04311632

The ClinicalTrials.gov registry entry for NCT04311632 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ITB-Med, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which ATG is the first listed.

NCT04311632 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04311632 about?

NCT04311632 is a clinical study titled "A Dose Escalation Study in de Novo Renal Transplantation". 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.

What is the current status of trial NCT04311632?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-05-26. Estimated completion is 2023-10-03.

What interventions are being tested in trial NCT04311632?

The interventions under investigation include: ATG (DRUG), Mycophenolate Mofetil (MMF) (DRUG), TCD601 (BIOLOGICAL), Corticosteroids (CS) (DRUG), Tacrolimus (TAC) (DRUG).

Who is sponsoring clinical trial NCT04311632?

This trial is sponsored by ITB-Med, which has 4 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.