← Back to Search

Immunosuppressant

TCD601 + Standard Transplant Medications for Kidney Transplant

Phase 2
Waitlist Available
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 aged 18 to 70 years
Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare the safety and effects of two different drugs in kidney transplant patients.

Who is the study for?
This trial is for adults aged 18 to 70 who need a new kidney from either a living non-identical donor or a deceased one, with the organ kept on ice less than 30 hours. They must understand and agree to the study's rules. People can't join if they've had a kidney transplant before, are getting an organ from an identical twin, received it after the donor's heart stopped, have high rejection risk, or need multiple organs.Check my eligibility
What is being tested?
The study tests different doses of TCD601 in people getting their first kidney transplant and compares it with rATG (a standard treatment). It looks at how safe TCD601 is and how the body reacts to it alongside usual drugs like Tacrolimus, Corticosteroids, and Mycophenolate Mofetil.See study design
What are the potential side effects?
Possible side effects may include reactions where TCD601 is given, changes in blood counts or immune system function due to ATG. Common transplant drug side effects like infections due to lowered immunity might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
I received a new kidney from a donor who was not a perfect match.
Select...
My kidney transplant had a cold storage time under 30 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Measure Peak Plasma Concentration (Cmax) over time.
Measure the Area under the plasma concentration versus time curve (AUC).
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Secondary outcome measures
Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time.
Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time.
Measure peripheral CD2-receptor occupancy following TCD601 administration

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment4 Interventions
TCD601 administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Group II: Arm 1Experimental Treatment4 Interventions
TCD601 administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Group III: Arm 3Active Control5 Interventions
ATG administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil (MMF)
2000
Completed Phase 4
~710
Tacrolimus (TAC)
2013
Completed Phase 2
~150
Corticosteroids (CS)
2015
Completed Phase 2
~80
TCD601
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

ITB-Med LLCLead Sponsor
9 Previous Clinical Trials
318 Total Patients Enrolled
Alan Slade, PharmDStudy ChairITB-Med LLC
Nick Hryciw, MAStudy DirectorITB-Med LLC
3 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

ATG (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04311632 — Phase 2
Kidney Transplant Research Study Groups: Arm 1, Arm 2, Arm 3
Kidney Transplant Clinical Trial 2023: ATG Highlights & Side Effects. Trial Name: NCT04311632 — Phase 2
ATG (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04311632 — Phase 2

Frequently Asked Questions

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

Is enrollment still available for this experiment?

"Clinicaltrials.gov states that this clinical trial is presently recruiting patients. It was initially published on May 26th 2021 and recently amended on October 28th 2022."

Answered by AI

What further investigations have been conducted concerning the effects of TCD601?

"Currently, 207 medical trials are in progress to evaluate the efficacy of TCD601 with 26 studies at Phase 3. While Philadelphia is a hub for this research, 1405 locations across the world are conducting clinical trials related to TCD601."

Answered by AI

Are older individuals eligible for participation within this research endeavor?

"To be eligible for this clinical study, patients must have a minimum age of 18 and cannot exceed the age of 70. For those under 18 years old, 84 trials are available while 235 can be found for those over 65 years old."

Answered by AI

What medical issue is TCD601 normally prescribed to treat?

"TCD601 is the primary medication utilized to treat dermatitis, atopic; however, it has also proven efficacious in treating liver and kidney transplant rejection as well as psoriasis."

Answered by AI

Who would be the ideal participants for this research endeavor?

"This study will accept 24 individuals aged between 18 and 70 who have recently undergone a kidney transplant from either a living or deceased donor. It is necessary that applicants be of both sexes, meeting the age requirements specified earlier."

Answered by AI

What risks have been associated with the use of TCD601?

"The safety of TCD601 has been estimated to be a 2 on the 1-3 scale, due to data from Phase 2 trials demonstrating its security but no evidence yet for efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Dose Escalation Study in de Novo Renal Transplantation
2021. "A Dose Escalation Study in de Novo Renal Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04311632.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top