Kidney TransplantationPhase 2NCT04311632
A Dose Escalation Study 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 4 sites in United States.
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
- 13 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 May 2021to 3 Oct 2023
- 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
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kansas University Medical Center
Kansas City, Kansas, 66160
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
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
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 administered with the 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 administered with the 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 | Active comparator | ATG administered with the 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-emergent Adverse Events as Assessed by CTCAE v5.0.
Measured: 12 months
Measure Peak 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 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 Rejection at 12 Months Post-transplant.
The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.
Measured: 12 months
To Assess the Change in Renal Function Over Time.
Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant).
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 posted17 Mar 2020
- Study start26 May 2021
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITB-Med LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick Hryciw, MA, Study director, ITB-Med LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311632
- Sponsor's protocol ID
- TCD601B102
- Status last verified
- Feb 2025
- First submitted
- 12 Mar 2020
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Feb 2025. 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
- NCT04311632
- Acronym / sponsor ID
- TCD601B102
- Conditions
- Kidney Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Posted 27 Feb 2025
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
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: TCD601, Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF)TCD601 administered with the 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 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Arm 3 | Active comparator | Drug: Tacrolimus (TAC), Drug: Corticosteroids (CS), Drug: Mycophenolate Mofetil (MMF), Drug: ATGATG administered with the 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 |
|---|---|---|
| TCD601Investigational Product | Biological | Arm 1, Arm 2 |
| Tacrolimus (TAC)Standard of Care Concomitant Immunosuppression | Drug | Arm 1, Arm 2, Arm 3 |
| Corticosteroids (CS)Standard of Care Concomitant Immunosuppression | Drug | Arm 1, Arm 2, Arm 3 |
| Mycophenolate Mofetil (MMF)Standard of Care Concomitant Immunosuppression | Drug | Arm 1, Arm 2, Arm 3 |
| ATGStandard of Care induction therapy in solid organ transplantation | Drug | Arm 3 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
Time frame: 12 months
Measure Peak 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 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 Rejection at 12 Months Post-transplant.
Time frame: 12 months
To Assess the Change in 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 27 Feb 2025.
- 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.
Nick Hryciw, MA study director
ITB-Med LLC
4 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, Tacrolimus (TAC) and Corticosteroids (CS) in people with Kidney Transplantation, run by ITB-Med LLC at 4 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 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: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 27 Feb 2025). 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-emergent 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 27 Feb 2025.