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Immunosuppressant

TCD601 + Belatacept 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
No Placebo-Only Group

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.
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.
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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
Secondary study objectives
Renal function in Arm 1 compared to Arm 2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~290
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
11 Previous Clinical Trials
303 Total Patients Enrolled
Kellie Kennon, BSNStudy DirectorITB-Med LLC
2 Previous Clinical Trials
108 Total Patients Enrolled
~35 spots leftby Jul 2025
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