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Monoclonal Antibodies

TCD601 for Kidney Transplant Tolerance

Phase 2
Recruiting
Research Sponsored by ITB-Med LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients ≥ 18 to 60 years of age.
Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test if TCD601 can help people who receive kidney transplants from living donors to better tolerate the organ.

Who is the study for?
This trial is for adults aged 18 to 60 who are receiving their first or second kidney transplant from a living donor who's at least half-matched genetically and has the same blood type. Participants must understand the study and agree to its terms. Pregnant women, those able to have children, or individuals with a history of cancer cannot join.Check my eligibility
What is being tested?
The trial is testing TCD601 in patients getting new kidneys from living donors. It aims to see if this drug can help patients accept their new organ without the immune system attacking it (called 'tolerance').See study design
What are the potential side effects?
While specific side effects of TCD601 aren't listed here, similar drugs may cause immune system suppression leading to increased infection risk, possible allergic reactions, and potential impact on liver and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.
Select...
I have received a kidney transplant from a partially matched living donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance
Secondary outcome measures
Incidence of biopsy proven acute rejection, death, and graft loss
The incidence of de novo DSA

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TCD601
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

ITB-Med LLCLead Sponsor
9 Previous Clinical Trials
319 Total Patients Enrolled
Nick Hryciw, MAStudy DirectorITB-MED
3 Previous Clinical Trials
71 Total Patients Enrolled

Media Library

TCD601 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04803058 — Phase 2
Kidney Transplant Research Study Groups: Arm 1
Kidney Transplant Clinical Trial 2023: TCD601 Highlights & Side Effects. Trial Name: NCT04803058 — Phase 2
TCD601 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803058 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are currently administering this trial?

"The current trial is being conducted in many locations, including UT Southwestern Medical Center (Dallas, Texas), University of Chicago (Chicago, Illinois) and Massachusetts General Hospital (Boston, Massachusetts)."

Answered by AI

To what demographic is this research endeavor best suited?

"If you meet the age bracket of 18 to 60 and possess healthy renal function, then you are qualified for this medical trial. Only 12 patients will be admitted into this study."

Answered by AI

Are applicants of all ages being considered for this research?

"This study is seeking patients aged 18 to 60, while 10 clinical trials are available for minors and 75 studies offer treatment solutions for seniors."

Answered by AI

What adverse effects have been associated with TCD601 in clinical research?

"Following a thorough review, TCD601 was rated 2 out of 3 due to its Phase 2 status. This implies there is knowledge on the drug's safety yet limited data validating it efficacy."

Answered by AI

Is participation in this experiment being accepted at the present time?

"According to clinicaltrials.gov, this medical research trial is not currently enrolling new participants; the initial post date was July 1st 2022 and it was last updated on June 13th of the same year. Although this trial has closed its recruitment window, 85 other studies are actively seeking volunteers at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PERSPECTIVE)
2022. "A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PERSPECTIVE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803058.
~4 spots leftby Dec 2024
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