Kidney TransplantationPhase 2NCT06365437
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
A Phase 2 study testing TCD601, Tacrolimus (TAC) and Corticosteroids (CS) in people with Kidney Transplantation, run by ITB-Med LLC at 7 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG 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
- Kidney Transplantation
- What is being tested?
- TCD601, Tacrolimus (TAC) and Corticosteroids (CS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 6 Jun 2021to 11 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 unrelated, or non-HLA identical living related donor.
- Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.
Who cannot join
- Multiple-organ transplant recipients
- 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
- Subjects at high immunological risk for rejection
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Skåne University Hospital
Malmö, 20502
Karolinska University Hospital
Stockholm, Huddinge, 14157
Austria2 sites
Innsbruck Medical University
Innsbruck, A-6020
University of Vienna
Vienna, 1090
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
Barcelona, 08907
About this study
Official title: A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601 (Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Conditions
- Kidney Transplantation
- Being tested
- TCD601, Tacrolimus (TAC), Corticosteroids (CS), Mycophenolate Mofetil (MMF), ATG
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
Tacrolimus (TAC)Drug
Standard of Care Concomitant Immunosuppression
Corticosteroids (CS)Drug
Standard of Care Concomitant Immunosuppression
Mycophenolate Mofetil (MMF)Drug
Standard of Care Concomitant Immunosuppression
ATGDrug
Standard of Care induction therapy in solid organ transplantation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Receives: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF) |
| Arm 2 | Experimental | TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Receives: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF) |
| Arm 3 | Experimental | TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Receives: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF) |
| Arm 4 | Experimental | TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Receives: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF) |
| Arm 5 | Active comparator | ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Receives: Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF); Drug: ATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
Measured: 12 months
Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measured: 12 months
Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).
The AUC from time zero to the last measurable concentration sampling time.
Measured: 12 months
Secondary outcomes (2)
The Incidence of Allograft Rejection at 12 Months Post-Transplant
Measured: 12 months
To Assess Renal Function Over Time
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 posted15 Apr 2024
- Study start6 Jun 2021
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Why it stopped: After enrolment was complete, and sufficient data was collected to fully characterize the highest dose cohort, study follow up was terminated by the sponsor for non-safety related reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT06365437
- Sponsor's protocol ID
- TCD601B101
- Status last verified
- Jan 2025
- First submitted
- 10 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601 (Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT06365437
- Acronym / sponsor ID
- TCD601B101
- Conditions
- Kidney Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After enrolment was complete, and sufficient data was collected to fully characterize the highest dose cohort, study follow up was terminated by the sponsor for non-safety related reasons.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Posted 12 Mar 2026
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 investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: TCD601, Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF)TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Arm 2 | Experimental | Biological: TCD601, Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF)TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Arm 3 | Experimental | Biological: TCD601, Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF)TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Arm 4 | Experimental | Biological: TCD601, Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF)TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Arm 5 | Active comparator | Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF), Drug: ATGATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 unrelated, or non-HLA identical living related donor.
- Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.
Key exclusion criteria (5 listed)
- Multiple-organ transplant recipients
- 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
- Subjects at high immunological risk for rejection
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 | Arm 1, Arm 2, Arm 3, Arm 4 |
| Tacrolimus (TAC)Standard of Care Concomitant Immunosuppression | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| Corticosteroids (CS)Standard of Care Concomitant Immunosuppression | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| Mycophenolate Mofetil (MMF)Standard of Care Concomitant Immunosuppression | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| ATGStandard of Care induction therapy in solid organ transplantation | Drug | Arm 5 |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
Time frame: 12 months
Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.
Time frame: 12 months
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).
Time frame: 12 months
The AUC from time zero to the last measurable concentration sampling time.
2 secondary outcomes
The Incidence of Allograft Rejection at 12 Months Post-Transplant
Time frame: 12 months
To Assess Renal Function Over Time
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCD601, Tacrolimus (TAC) and Corticosteroids (CS) in people with Kidney Transplantation, run by ITB-Med LLC at 7 sites in 3 countries.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Austria, Spain. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0. (time frame: 12 months). The study lists 3 primary outcomes in all. 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 12 Mar 2026.