Renal TransplantationPhase 2ASCENDNCT05669001
A Study of TCD601 in de Novo Renal Transplant Recipients
A Phase 2 study testing TCD601, belatacept and ATG in people with Renal Transplantation, run by ITB-Med LLC at 18 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- TCD601, belatacept and ATG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 18 sitesUnited States
- Study dates
- 28 Dec 2023to 10 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Male or female patients ≥ 18 to 70 years of age
- Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Who cannot join
- Subjects who have received a kidney allograft previously
- Recipient of a kidney from an HLA identical living related donor
- Recipient of a kidney from a donor after cardiac death
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University Hospital
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Health
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Henry Ford Hospital
Detroit, Michigan, 48202
Inova Fairfax Hospital Medical Campus
Falls Church, Virginia, 22042
Houston Methodist Hospital
Houston, Texas, 77030
Loyola University Medical Center
Maywood, Illinois, 60153
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of California Davis Medical Center
Sacramento, California, 95817
University of California San Francisco Medical Center
San Francisco, California, 94143
Tampa General Hospital
Tampa, Florida, 33606
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
- Conditions
- Renal Transplantation
- Being tested
- TCD601, belatacept, ATG, TAC, MPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCD601Biological
Also called siplizumab
Investigational Product
belataceptBiological
Study Product
ATGDrug
Also called antithymocyte globulin
Comparator
TACDrug
Also called tacrolimus
Comparator
MPADrug
Also called mycophenolic acid
Immunosuppression Therapy
CorticosteroidsDrug
Immunosuppression Therapy
| Study group | Role | What they receive |
|---|---|---|
| TCD601 (siplizumab) | Experimental | TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids Receives: Biological: TCD601; Biological: belatacept; Drug: MPA; Drug: Corticosteroids |
| ATG | Active comparator | Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids Receives: Drug: ATG; Drug: TAC; Drug: MPA; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
The number of adverse events and serious adverse events
Measured: 12 months
Secondary outcomes (1)
Renal function in Arm 1 compared to Arm 2
renal function using estimated glomerular filtration rate (eGFR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start28 Dec 2023
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITB-Med LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredrik Juhlin, Study director, ITB-Med LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669001
- Sponsor's protocol ID
- TCD601B203
- Acronym
- ASCEND
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)
- ClinicalTrials.gov ID
- NCT05669001
- Acronym / sponsor ID
- ASCEND / TCD601B203
- Conditions
- Renal Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCD601 (siplizumab) | Experimental | Biological: TCD601, Biological: belatacept, Drug: MPA, Drug: CorticosteroidsTCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids |
| ATG | Active comparator | Drug: ATG, Drug: TAC, Drug: MPA, Drug: CorticosteroidsAntithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Male or female patients ≥ 18 to 70 years of age
- Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Key exclusion criteria (3 listed)
- Subjects who have received a kidney allograft previously
- Recipient of a kidney from an HLA identical living related donor
- Recipient of a kidney from a donor after cardiac death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCD601Also: siplizumabInvestigational Product | Biological | TCD601 (siplizumab) |
| belataceptStudy Product | Biological | TCD601 (siplizumab) |
| ATGAlso: antithymocyte globulinComparator | Drug | ATG |
| TACAlso: tacrolimusComparator | Drug | ATG |
| MPAAlso: mycophenolic acidImmunosuppression Therapy | Drug | ATG, TCD601 (siplizumab) |
| CorticosteroidsImmunosuppression Therapy | Drug | ATG, TCD601 (siplizumab) |
Primary outcome
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
Time frame: 12 months
The number of adverse events and serious adverse events
1 secondary outcome
Renal function in Arm 1 compared to Arm 2
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Juhlin study director
ITB-Med LLC
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCD601, belatacept and ATG in people with Renal Transplantation, run by ITB-Med LLC at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.