Renal Transplant Failure and RejectionPhase 2MODERNIZE1NCT07508787
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
A Phase 2 study testing Siplizumab and Rabbit anti-thymocyte globulin in people with Renal Transplant Failure and Rejection, run by Nefro Avillion Clinical Development, LLC at 14 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease. The main questions it aims to answer are: How many adverse events do participants receiving two different doses of siplizumab have compared to rabbit… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplant Failure and Rejection
- What is being tested?
- Siplizumab and Rabbit anti-thymocyte globulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 29 Jun 2026to 28 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Recipients of a renal allograft from a non-HLA identical living or deceased donor.
- Recipients of a kidney with a cold ischemia time < 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, must agree to use highly effective methods of contraception.
Who cannot join
- Transplant recipients seronegative for EBV.
- Transplant recipients receiving a kidney from a non-heart beating donor (ie, DCD) whose organ is retrieved from an uncontrolled DCD or whose donor age > 55 years of age.
- Multi-organ transplant recipients (eg, kidney-pancreas, organ other than kidney), dual-kidney transplant recipients, recipients with more than one prior kidney transplant, or hematopoietic stem cell transplantation recipients.
- Presence of current or historical DSA via single-antigen bead assay or local SoC. The MFI cut-off value used to determine the presence of DSA will be defined as per the institutional SoC. Results within 3 months prior to transplant are acceptable.
- Crossmatch positive (isolated positive B cell crossmatches are not an exclusion criterion).
- ABO-incompatible recipient.
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- Administration of complement inhibitor therapy within 6 months prior to the transplant, or likely to require treatment with complement inhibitor therapy during the study.
- Participants receiving immunosuppressive therapies prior to transplant for pre-existing conditions must be candidates for the protocol-defined regimen.
- History of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix.
- Seropositive for human immunodeficiency virus or hepatitis B surface antigen. Participants who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response after anti-HCV treatment.
- Recipient of a kidney from a donor who tests positive for human immunodeficiency virus or hepatitis B surface antigen/hepatitis B core protein.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (eg, siplizumab, rATG, TAC, MPA derivatives, CS).
- Evidence of active tuberculosis (TB) infection (participants with a history of latent TB may become eligible after treatment with anti-TB therapy according to national guidelines).
- Participants with severe systemic infection(s), at the time of screening or within 2 weeks prior to randomization
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 3 countries
United States11 sites, 11 recruiting
- Recruiting
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, 48109
Nerissa Reister, Clinical Research Coordinator, 734-763-5718, naflow@med.umich.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Emily Temponi, Study Coordinator, 404-712-1114, emily.k.temponi@emory.edu
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
David Wojciechowski, DO, 214-645-7846, David.Wojciechowski@UTSouthwestern.edu
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Matthew Callaghan, 313-916-4596, mcallag2@hfhs.org
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Alma Khan, MSN, CCRC, 703-776-5912, Alma.Khan2@inova.org
- Recruiting
Cooperman Barnabus Medical Center
Livingston, New Jersey, 07039
Jayrol Mock, APN, 973-322-2339, Jayrol.Mock2@rwjbh.org
- Recruiting
Virginia Commonwealth University Health
Richmond, Virginia, 23298
Meron Zeleke, 804-628-4969, Meron.Zeleke@vcuhealth.org
- Not yet recruiting
UC Davis Medical Center
Sacramento, California, 95817
Timothy Huynh, Clinical Research Coordinator, 916-703-4471, ttihuynh@health.ucdavis.edu
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Belinda Pan, Research Coordinator, 206-598-1562, bcpan@uw.edu
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Jennifer Schmidt, BSN, RN, 813-844-7041, jenniferanilsen@tgh.org
- Recruiting
UMass Chan Medical Center
Worcester, Massachusetts, 01655
Anil Chandraker, MD, 508-334-7087, anil.chandraker4@umassmed.edu
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Study Coordinator, +34 932746000, assajos.nefrologia@vhir.org
- Recruiting
Hospital Universitario Regional de Malaga
Málaga, 29010
Study Coordinator, +34 951291174, estudios.clinicos@ibima.eu
Brazil1 site, 1 recruiting
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Centro Integrado de Pesquisa
São José do Rio Preto
Research Coordinator, +55 (17) 3201-5054, osvaldo.junior@centrodepesquisacip.com.br
Mario Abbud Filho, MD
About this study
Official title: Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Finding, Active-Controlled Study of Siplizumab (TCD601) Compared to Rabbit Anti-Thymocyte Globulin in Renal Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression With Tacrolimus, Mycophenolic Acid and Corticosteroids
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease. The main questions it aims to answer are:
How many adverse events do participants receiving two different doses of siplizumab have compared to rabbit anti-thymocyte globulin (rATG)?
Read more
How many participants successfully keep their kidney transplant after receiving siplizumab or rATG? This will be calculated as those participants that did not: die; have their kidney fail to work properly (graft loss); their body rejects their transplant (tissue sample (biopsy)-proven acute rejection: BPAR); or who were lost to follow-up.
How does the body respond to siplizumab after dosing at each of the 2 dose levels?
How does siplizumab work in the body compared to rATG?
Selected participants will be divided into 3 groups. In 2 of the groups, participants will be given siplizumab at one of the two study medicine doses. Participants in the third group will be given rATG. All participants will take the usual anti-rejection medicines given before, during, and after a kidney transplant. All participants will also be given medicines before the study drug to lower the risk of reactions, and medicines used to prevent or treat infections after the transplant.
Participants will be asked to provide their medical history at the first visit at the study site where you will have your kidney transplant. At the first visit and other visits participants will be asked to provide their medication history, have a physical exam, check vital signs, have blood drawn for tests, and have non-invasive tests that record the electrical activity of your heart (ECG) and blood draws.
Participants will be monitored for 12 months after transplant surgery.
Read the detailed description
Approximately 120 renal transplant candidates requiring induction therapy will be enrolled 1:1:1 to receive 1 of 2 dose levels of siplizumab or to the comparator rATG.
Randomization will be stratified by donor status (living vs donation after brain death vs donation after cardiac death) to ensure similar proportions of donor types in each study arm. All participants will also receive:
- A triple regimen (TAC, MPA, and CS) of background immunosuppressive therapy for the duration of the study.
- Premedication prior to study treatment infusions.
- Infection prophylaxis
This clinical trial will evaluate the safety of an anti-cluster of differentiation 2 (CD2) monoclonal antibody, siplizumab, compared to rATG as induction therapy in renal transplant recipients.
Following hospital discharge, participants will undergo assessments and procedures as indicated in the protocol through Month 12 or EOS, unless more frequent visits are required per local SoC or for laboratory specimen collection.
Safety assessments will include physical examinations, ECGs, vital signs, viral surveillance and monitoring, standard clinical laboratory evaluations completed centrally (hematology, clinical chemistry, urinalysis), and AE/SAE monitoring.
Final analysis will be performed when all participants have completed 12-month follow-up visits post-transplant or have otherwise ended the trial. This analysis will be performed to evaluate the safety of siplizumab at 2 dose levels compared to rATG.
- Conditions
- Renal Transplant Failure and Rejection
- Being tested
- Siplizumab, Rabbit anti-thymocyte globulin
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiplizumabDrug
Also called TCD601
A non-agonistic, humanized, anti-CD2 monoclonal antibody of the IgG1κ class
Rabbit anti-thymocyte globulinDrug
Also called Thymoglobulin
An anti-human thymocyte immunoglobulin preparation made of purified polyclonal antibodies derived from rabbits
| Study group | Role | What they receive |
|---|---|---|
| Low dose siplizumab | Experimental | Not described Receives: Drug: Siplizumab |
| High dose siplizumab | Experimental | Not described Receives: Drug: Siplizumab |
| Rabbit anti-thymocyte globulin | Active comparator | Not described Receives: Drug: Rabbit anti-thymocyte globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of 2 dose levels of siplizumab versus rATG.
Number and percentage of participants at 12 months post-transplant experiencing adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
Measured: 12 months
Secondary outcomes (9)
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
- Composite incidence of BPAR, death, graft loss, and loss-to-follow-up.
- Incidence of participants who experienced BPAR as defined by central pathology (blinded independent central review using Banff Allograft Pathology Scoring).
- Incidence of treated BPAR and steroid-resistant BPAR.
Measured: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
- Grade of BPAR.
Measured: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
- Severity of BPAR.
Measured: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
- Time to first BPAR for each participant.
- Time to graft loss for each participant.
- Time to death for each participant.
Measured: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
- Participant survival at 12 months.
- Graft survival at 12 months.
Measured: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
- Number of participants requiring for-cause renal allograft biopsy assessments over 12 months post-transplant.
Measured: 12 months
Assessment of the pharmacokinetics (PK) of 2 dose levels of siplizumab.
Siplizumab Cmax (maximum blood concentration) over 12 weeks post-transplant.
Measured: 12 weeks
Assessment of the pharmacokinetics (PK) of 2 dose levels of siplizumab.
Siplizumab AUC (area under the concentration-time curve) over 12 weeks post-transplant.
Measured: 12 weeks
Assessment of the pharmacodynamics (PD) of 2 dose levels of siplizumab versus rATG.
Depletion and recovery of lymphocyte count by subset (total lymphocytes; CD3+, CD4+, and CD8+ T cells; CD19+ B cells; CD56+ NK cells) over 12 months 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 posted2 Apr 2026
- Study start29 Jun 2026
- Primary completion28 Mar 2028 (estimated)
- Study completion28 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Failure and RejectionStudies 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
- Model description
- Participants will be randomized in a 1:1:1 ratio to a low dose of siplizumab, a high dose of siplizumab and rATG.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nefro Avillion Clinical Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508787
- Sponsor's protocol ID
- TCD601B205
- Acronym
- MODERNIZE1
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Finding, Active-Controlled Study of Siplizumab (TCD601) Compared to Rabbit Anti-Thymocyte Globulin in Renal Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression With Tacrolimus, Mycophenolic Acid and Corticosteroids
- ClinicalTrials.gov ID
- NCT07508787
- Acronym / sponsor ID
- MODERNIZE1 / TCD601B205
- Conditions
- Renal Transplant Failure and Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nefro Avillion Clinical Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 28 Mar 2028 (estimated)
- Study completion
- 28 Mar 2028 (estimated)
- First posted
- 2 Apr 2026 (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 goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease. The main questions it aims to answer are:
How many adverse events do participants receiving two different doses of siplizumab have compared to rabbit anti-thymocyte globulin (rATG)?
How many participants successfully keep their kidney transplant after receiving siplizumab or rATG? This will be calculated as those participants that did not: die; have their kidney fail to work properly (graft loss); their body rejects their transplant (tissue sample (biopsy)-proven acute rejection: BPAR); or who were lost to follow-up.
How does the body respond to siplizumab after dosing at each of the 2 dose levels?
How does siplizumab work in the body compared to rATG?
Selected participants will be divided into 3 groups. In 2 of the groups, participants will be given siplizumab at one of the two study medicine doses. Participants in the third group will be given rATG. All participants will take the usual anti-rejection medicines given before, during, and after a kidney transplant. All participants will also be given medicines before the study drug to lower the risk of reactions, and medicines used to prevent or treat infections after the transplant.
Participants will be asked to provide their medical history at the first visit at the study site where you will have your kidney transplant. At the first visit and other visits participants will be asked to provide their medication history, have a physical exam, check vital signs, have blood drawn for tests, and have non-invasive tests that record the electrical activity of your heart (ECG) and blood draws.
Participants will be monitored for 12 months after transplant surgery.
Detailed description
Approximately 120 renal transplant candidates requiring induction therapy will be enrolled 1:1:1 to receive 1 of 2 dose levels of siplizumab or to the comparator rATG.
Randomization will be stratified by donor status (living vs donation after brain death vs donation after cardiac death) to ensure similar proportions of donor types in each study arm. All participants will also receive:
- A triple regimen (TAC, MPA, and CS) of background immunosuppressive therapy for the duration of the study.
- Premedication prior to study treatment infusions.
- Infection prophylaxis
This clinical trial will evaluate the safety of an anti-cluster of differentiation 2 (CD2) monoclonal antibody, siplizumab, compared to rATG as induction therapy in renal transplant recipients.
Following hospital discharge, participants will undergo assessments and procedures as indicated in the protocol through Month 12 or EOS, unless more frequent visits are required per local SoC or for laboratory specimen collection.
Safety assessments will include physical examinations, ECGs, vital signs, viral surveillance and monitoring, standard clinical laboratory evaluations completed centrally (hematology, clinical chemistry, urinalysis), and AE/SAE monitoring.
Final analysis will be performed when all participants have completed 12-month follow-up visits post-transplant or have otherwise ended the trial. This analysis will be performed to evaluate the safety of siplizumab at 2 dose levels compared to rATG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to a low dose of siplizumab, a high dose of siplizumab and rATG.
| Arm | Type | Receives |
|---|---|---|
| Low dose siplizumab | Experimental | Drug: Siplizumab |
| High dose siplizumab | Experimental | Drug: Siplizumab |
| Rabbit anti-thymocyte globulin | Active comparator | Drug: Rabbit anti-thymocyte globulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipients of a renal allograft from a non-HLA identical living or deceased donor.
- Recipients of a kidney with a cold ischemia time < 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, must agree to use highly effective methods of contraception.
Key exclusion criteria (14 listed)
- Transplant recipients seronegative for EBV.
- Transplant recipients receiving a kidney from a non-heart beating donor (ie, DCD) whose organ is retrieved from an uncontrolled DCD or whose donor age > 55 years of age.
- Multi-organ transplant recipients (eg, kidney-pancreas, organ other than kidney), dual-kidney transplant recipients, recipients with more than one prior kidney transplant, or hematopoietic stem cell transplantation recipients.
- Presence of current or historical DSA via single-antigen bead assay or local SoC. The MFI cut-off value used to determine the presence of DSA will be defined as per the institutional SoC. Results within 3 months prior to transplant are acceptable.
- Crossmatch positive (isolated positive B cell crossmatches are not an exclusion criterion).
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 |
|---|---|---|
| SiplizumabAlso: TCD601A non-agonistic, humanized, anti-CD2 monoclonal antibody of the IgG1κ class | Drug | High dose siplizumab, Low dose siplizumab |
| Rabbit anti-thymocyte globulinAlso: ThymoglobulinAn anti-human thymocyte immunoglobulin preparation made of purified polyclonal antibodies derived from rabbits | Drug | Rabbit anti-thymocyte globulin |
Primary outcome
Assessment of the safety of 2 dose levels of siplizumab versus rATG.
Time frame: 12 months
Number and percentage of participants at 12 months post-transplant experiencing adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
9 secondary outcomes
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
Time frame: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
Time frame: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
Time frame: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
Time frame: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
Time frame: 12 months
Assessment of the incidence of composite efficacy failure (defined as death, graft loss, biopsy-proven acute rejection [BPAR], or loss-to-follow-up) and their individual components.
Time frame: 12 months
Assessment of the pharmacokinetics (PK) of 2 dose levels of siplizumab.
Time frame: 12 weeks
Assessment of the pharmacokinetics (PK) of 2 dose levels of siplizumab.
Time frame: 12 weeks
Assessment of the pharmacodynamics (PD) of 2 dose levels of siplizumab versus rATG.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
14 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 Siplizumab and Rabbit anti-thymocyte globulin in people with Renal Transplant Failure and Rejection, run by Nefro Avillion Clinical Development, LLC at 14 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Spain, Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety of 2 dose levels of siplizumab versus rATG. (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 6 Oct 2026.