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Immunosuppressant

TCD601 (siplizumab) for Kidney Transplant (ASCEND Trial)

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 70 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ASCEND Trial Summary

This trial aims to determine if using TCD601 in combination with Belatacept is safe and effective for de novo renal transplant patients compared to the usual immunosuppression therapy.

Who is the study for?
This trial is for adults aged 18 to 70 who are getting a new kidney from either a living donor or deceased with a matching blood type but not necessarily an exact tissue match. They must understand the study and agree to participate.Check my eligibility
What is being tested?
The trial is testing TCD601 in combination with Belatacept against standard immunosuppression treatments in patients receiving their first kidney transplant, aiming to see if it's safe and works well.See study design
What are the potential side effects?
Potential side effects may include increased risk of infection, possible drug reactions, changes in blood pressure or sugar levels, gastrointestinal issues, and potential impact on liver and kidney function.

ASCEND Trial 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.

ASCEND Trial 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
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
Secondary outcome measures
Renal function in Arm 1 compared to Arm 2

ASCEND Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TCD601 (siplizumab)Experimental Treatment4 Interventions
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
Group II: ATGActive Control4 Interventions
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TCD601
2021
Completed Phase 2
~20
belatacept
2017
Completed Phase 4
~280
MPA
2014
Completed Phase 4
~30
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

ITB-Med LLCLead Sponsor
9 Previous Clinical Trials
241 Total Patients Enrolled
Kellie Kennon, BSNStudy DirectorITB-Med LLC
2 Previous Clinical Trials
108 Total Patients Enrolled

Frequently Asked Questions

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

In how many distinct clinics is this experimental investigation currently being conducted?

"This investigation is being conducted at Emory University Hospital in Atlanta, Georgia; University of Nebraska Medical Center in Omaha, Nebraska; Scripps Green Hospital in La Jolla, California; and an additional 17 locations."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking individuals to participate. The initial posting date was on January 1st, 2024 and the most recent update occurred on January 9th, 2024. A total of 90 participants will be enrolled across a network of 17 different locations."

Answered by AI

Are patients currently able to enroll in this ongoing study?

"Indeed, the data available on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The study was initially posted on January 1st, 2024 and last updated on January 9th, 2024. A total of 90 individuals are being sought to participate in the clinical trial across a network of 17 different sites."

Answered by AI

Has the Food and Drug Administration granted approval for TCD601 (siplizumab) to be used as a medical treatment?

"Our estimation at Power rates the safety of TCD601 (siplizumab) as a 2 on a scale from 1 to 3. This rating aligns with it being a Phase 2 trial, indicating that there is some existing data supporting its safety but no evidence yet demonstrating efficacy."

Answered by AI

Which individuals are eligible to participate in this research study?

"The target enrollment for this trial is 90 individuals aged between 18 and 70 who have undergone kidney transplantation. In addition to meeting the age criteria, patients must possess the ability to comprehend study obligations and provide written informed consent prior to undergoing any assessments. The study specifically seeks male or female participants who received a fresh renal transplant from either a deceased donor with heart activity or a living related donor who does not share HLA compatibility but has ABO compatibility."

Answered by AI

Is the clinical trial inclusive of individuals who are older than 65 years?

"To be eligible for enrolment in this clinical trial, individuals must be at least 18 years old and no older than 70."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of TCD601 in de Novo Renal Transplant Recipients
2023. "A Study of TCD601 in de Novo Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669001.
~60 spots leftby Jul 2025
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