Kidney Transplant RecipientPhase 1RTB-016NCT05975450
Subcutaneous Abatacept in Renal Transplant Recipients
A Phase 1 study testing Abatacept 125Mg/Ml Syringe in people with Kidney Transplant Recipient, run by Idelberto Badell at 2 sites in United States.
Trial summary
After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant Recipient
- What is being tested?
- Abatacept 125Mg/Ml Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2023to 14 Feb 2025
- Phase
- Phase 1
- 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
- Must be able to understand and provide informed consent.
- Male or Female, 18-70 years of age at the time of enrollment (all races and ethnicities)
- Negative crossmatch (virtual or physical) at the time of transplant
- No less than 8 weeks, no more than 20 weeks post-transplant at enrollment
- A first-time renal transplant who has been treated with belatacept from the time of transplant, receiving tacrolimus (target trough 3-5 ng/ml), mycophenolate mofetil (or mycophenolic acid or azathioprine), prednisone (also see exclusion criteria).
- eGFR ≥ 40ml/min/m2 [using 2021 the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation].
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- Prior documented evidence of Epstein-Barr virus (EBV) seropositivity must be available.
- Female study participants of childbearing potential must have a negative pregnancy test before enrollment.
- Agreement to use contraception that is more than 80% effective.
- Vaccines are current as per the Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials.
- Study participants must have a negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved Interferon Gamma Release Assay (IGRA) blood test, such as QuantiFERON®-Gold tuberculosis (TB) or T-SPOT®-TB assay. PPD or IGRA testing must be documented to have been performed within the 52 weeks before enrollment. Patients with latent TB may become eligible after completion of treatment.
Who cannot join
- Inability or unwillingness of a study participant to give written informed consent or comply with the study protocol.
- Recipient of previous organ transplant of any type.
- Multi-organ transplant.
- Calculated Panel Reactive Antibody (cPRA) >80 at the time of enrollment.
- History of any episode of biopsy-proven Banff rejection (including borderline rejection or any grade of acute TCMR) before enrollment.
- History of any malignancy including lymphoma within 5 years of enrollment. Study participants with curatively treated non-melanomatous skin cancer or curatively treated cervical carcinoma in situ may be enrolled.
Show all 22Show fewer
- Any past or current issue which in the opinion of the investigator may pose additional risks to the participant in the study, may interfere with the study participant's ability to comply with the study requirements, or may impact the quality or interpretation of the data obtained from the study.
- Human immunodeficiency virus (HIV): individuals known to be HIV positive.
- Hepatitis C virus (HCV): any study participant who receives a kidney from a seropositive or HCV RNA PCR-positive donor is ineligible. Any study participant who was HCV RNA PCR positive at transplant is ineligible. Any study participant with a history of HCV seropositivity or HCV infection who has not met the criteria for sustained spontaneous clearance or sustained viral response to therapy is ineligible.
- Hepatitis B virus (HBV): Individuals with any of the following are NOT eligible:
- Recipient or donor positive for hepatitis B surface antigen (HBsAg)
- Recipient or donor positive for antibodies to hepatitis B core antigen (anti-HBc)
- Recipient or donor is known to have had a positive HBV DNA PCR
- Evidence of CMV viremia or clinical CMV infection at any time after transplant.
- Kidney recipients who were CMV seronegative who received an organ from a CMV seropositive donor.
- BK viremia of greater than 4.3 DNA log copies/ml (greater than 20,000 copies/ml) at any time post-transplant.
- Active uncontrolled infection within 1 month of enrollment.
- Clinically significant proteinuria (urinary protein/Cr ratio >1.0).
- Receiving belatacept at a dose other than 5 mg/kg body weight.
- Receiving mycophenolate mofetil at a dose of less than 1000 mg daily (or mycophenolic acid or azathioprine equivalent).
- Receiving prednisone at a dose greater than 5 mg daily.
- Presence of donor-specific antibody by Luminex single antigen bead assay.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory Hospital
Atlanta, Georgia, 30322
About this study
Official title: Early Substitution of Subcutaneous Abatacept for Belatacept as Costimulation Blockade to Minimize Calcineurin Inhibitors (CNI) Exposure After Kidney Transplantation
After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. These drugs make it possible for a person who receives the transplant to accept the "foreign" kidney. Most patients who get a transplant need to take anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work.
Researchers are looking to learn whether abatacept is as good as belatacept in preventing rejection, whether there are other benefits or harms associated with abatacept treatment, and possibly allows greater flexibility on patient's travel and time since abatacept is self-administered at home.
Read more
This study is being done to answer these questions:
Are weekly abatacept injections under the skin a safe and effective substitute for monthly belatacept intravenous (IV) infusions? and How well does the kidney function after switching from belatacept to abatacept?
Read the detailed description
This is a Phase I, open-label, prospective, single-arm single-center study to evaluate the feasibility, effectiveness, and safety of a regimen substituting subcutaneous abatacept early post-transplant in place of intravenous belatacept as an immunosuppressant in first-time renal transplant recipients.
There is a single arm in this study; the Investigational (abatacept) group. Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
- Conditions
- Kidney Transplant Recipient
- Being tested
- Abatacept 125Mg/Ml Syringe
- Keywords
- Renal Transplant, abatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept 125Mg/Ml SyringeDrug
Also called Orencia
Participants on a qualifying belatacept regimen (with low-dose tacrolimus, mycophenylate mofetil (MMF), and prednisone) will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
- Abatacept 125 mg subcutaneous weekly
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Participants on a qualifying belatacept regimen will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study. Receives: Drug: Abatacept 125Mg/Ml Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Are Compliant With Self-administration
Compliance and self-administration will be measured using the abatacept administration logs and autoinjector accountability.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated Rejection (aTCMR) or Antibody-mediated Rejection (ABMR) as Defined by Banff Criteria at or Before 12 Months After Transplantation.
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Presenting Serious Adverse Events
Assessments of serious adverse events will be completed at each study visit from the time abatacept starts through 12 months post-transplant.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Serious Infections
Any serious infection requiring hospitalization or prolonged therapy, including but not limited to treatment ≥ 20 days, will be documented.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude
All subjects will be monitored for CMV infection by quantitative polymerase chain reaction (PCR) in the blood per the Emory Transplant Center standard of care protocol, CMV viremia stratified by count ≥35 but <10,000 or ≥ 10,000.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Patients With BK Viremia Stratified by the Magnitude
Undetected, >0 but < 1,000, ≥ 1,000 but <10,000, or ≥ 10,000 - 100,000, ≥100,000 or stratified by log, which is reported as a result.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Develop Any Malignancy
Incidence of any malignancy, including Post-Transplant Lymphoproliferative Disorder (PTLD)
Measured: Up to 12 months post-transplantation, an average of 8 months
Secondary outcomes (10)
Number of Participants Experiencing the Composite Outcome of Death or Allograft Failure
Death and/or allograft failure at or before 12 months after transplantation
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Biopsy-proven Acute T-cell Mediated Cellular Rejection (BP-aTCMR)
Incidence of biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Treated for Rejection
The number of participants treated for rejection with any of the following: i) corticosteroids within 12 months, ii) T-cell depleting therapy within 12 months, iii) any other treatment for rejection within 12 months of transplantation
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Treated for Acute Rejection Due to Clinical Suspicion Rather Than BP-aTCMR or BP-aABMR Within 12 Months of Transplantation.
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Biopsy-proven Active Antibody-mediated Rejection (BP-aABMR)
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Measured: Up to 12 months post-transplantation, an average of 8 months
Time to Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
Calculations will be made from the start of abatacept through to 12 months post-transplant. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Measured: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Develop De-novo Donor Specific Antibody (DSA)
Number of participants who develop de-novo DSA
Measured: Up to 12 months post-transplantation, an average of 8 months
Estimated Glomerular Filtration Rate (eGFR)
The eGFR will be calculated at the time abatacept is started and 12 months post-transplant
Measured: Baseline and 12 months post-transplantation
Number of Days to Events [TCMR, ABMR, De-novo Specific Antibodies (DSA) Formation, Graft Loss].
All events will be documented, and calculations will be made from the start of abatacept through 12 months post-transplant.
Measured: Up to 12 months post-transplantation, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start2 Aug 2023
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
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 Transplant RecipientStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idelberto Badell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Idelberto Badell, Emory University
- Investigators
- Idelberto R Badell, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975450
- Sponsor's protocol ID
- STUDY00005929
- Other IDs
- U01AI138909
- Acronym
- RTB-016
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2023
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Substitution of Subcutaneous Abatacept for Belatacept as Costimulation Blockade to Minimize Calcineurin Inhibitors (CNI) Exposure After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05975450
- Acronym / sponsor ID
- RTB-016 / STUDY00005929
- Conditions
- Kidney Transplant Recipient
- Keywords
- Renal Transplant, abatacept
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Idelberto BadellUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. These drugs make it possible for a person who receives the transplant to accept the "foreign" kidney. Most patients who get a transplant need to take anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work.
Researchers are looking to learn whether abatacept is as good as belatacept in preventing rejection, whether there are other benefits or harms associated with abatacept treatment, and possibly allows greater flexibility on patient's travel and time since abatacept is self-administered at home.
This study is being done to answer these questions:
Are weekly abatacept injections under the skin a safe and effective substitute for monthly belatacept intravenous (IV) infusions? and How well does the kidney function after switching from belatacept to abatacept?
Detailed description
This is a Phase I, open-label, prospective, single-arm single-center study to evaluate the feasibility, effectiveness, and safety of a regimen substituting subcutaneous abatacept early post-transplant in place of intravenous belatacept as an immunosuppressant in first-time renal transplant recipients.
There is a single arm in this study; the Investigational (abatacept) group. Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: Abatacept 125Mg/Ml SyringeParticipants on a qualifying belatacept regimen will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be able to understand and provide informed consent.
- Male or Female, 18-70 years of age at the time of enrollment (all races and ethnicities)
- Negative crossmatch (virtual or physical) at the time of transplant
- No less than 8 weeks, no more than 20 weeks post-transplant at enrollment
- A first-time renal transplant who has been treated with belatacept from the time of transplant, receiving tacrolimus (target trough 3-5 ng/ml), mycophenolate mofetil (or mycophenolic acid or azathioprine), prednisone (also see exclusion criteria).
Key exclusion criteria (22 listed)
- Inability or unwillingness of a study participant to give written informed consent or comply with the study protocol.
- Recipient of previous organ transplant of any type.
- Multi-organ transplant.
- Calculated Panel Reactive Antibody (cPRA) >80 at the time of enrollment.
- History of any episode of biopsy-proven Banff rejection (including borderline rejection or any grade of acute TCMR) before enrollment.
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 |
|---|---|---|
| Abatacept 125Mg/Ml SyringeAlso: OrenciaParticipants on a qualifying belatacept regimen (with low-dose tacrolimus, mycophenylate mofetil (MMF), and prednisone) will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant: Costimulation blockade: - Abatacept 125 mg subcutaneous weekly | Drug | Abatacept |
Primary outcome
Number of Participants Who Are Compliant With Self-administration
Time frame: Up to 12 months post-transplantation, an average of 8 months
Compliance and self-administration will be measured using the abatacept administration logs and autoinjector accountability.
Number of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated Rejection (aTCMR) or Antibody-mediated Rejection (ABMR) as Defined by Banff Criteria at or Before 12 Months After Transplantation.
Time frame: Up to 12 months post-transplantation, an average of 8 months
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Number of Participants Presenting Serious Adverse Events
Time frame: Up to 12 months post-transplantation, an average of 8 months
Assessments of serious adverse events will be completed at each study visit from the time abatacept starts through 12 months post-transplant.
Number of Participants With Serious Infections
Time frame: Up to 12 months post-transplantation, an average of 8 months
Any serious infection requiring hospitalization or prolonged therapy, including but not limited to treatment ≥ 20 days, will be documented.
Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude
Time frame: Up to 12 months post-transplantation, an average of 8 months
All subjects will be monitored for CMV infection by quantitative polymerase chain reaction (PCR) in the blood per the Emory Transplant Center standard of care protocol, CMV viremia stratified by count ≥35 but <10,000 or ≥ 10,000.
Number of Patients With BK Viremia Stratified by the Magnitude
Time frame: Up to 12 months post-transplantation, an average of 8 months
Undetected, >0 but < 1,000, ≥ 1,000 but <10,000, or ≥ 10,000 - 100,000, ≥100,000 or stratified by log, which is reported as a result.
Number of Participants Who Develop Any Malignancy
Time frame: Up to 12 months post-transplantation, an average of 8 months
Incidence of any malignancy, including Post-Transplant Lymphoproliferative Disorder (PTLD)
10 secondary outcomes
Number of Participants Experiencing the Composite Outcome of Death or Allograft Failure
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Biopsy-proven Acute T-cell Mediated Cellular Rejection (BP-aTCMR)
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Treated for Rejection
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Treated for Acute Rejection Due to Clinical Suspicion Rather Than BP-aTCMR or BP-aABMR Within 12 Months of Transplantation.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Biopsy-proven Active Antibody-mediated Rejection (BP-aABMR)
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
Time frame: Up to 12 months post-transplantation, an average of 8 months
Time to Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Develop De-novo Donor Specific Antibody (DSA)
Time frame: Up to 12 months post-transplantation, an average of 8 months
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and 12 months post-transplantation
Number of Days to Events [TCMR, ABMR, De-novo Specific Antibodies (DSA) Formation, Graft Loss].
Time frame: Up to 12 months post-transplantation, an average of 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Idelberto R Badell, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept 125Mg/Ml Syringe in people with Kidney Transplant Recipient, run by Idelberto Badell at 2 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 11 inclusion and 22 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 3 Apr 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 Who Are Compliant With Self-administration (time frame: Up to 12 months post-transplantation, an average of 8 months). The study lists 7 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 3 Apr 2026.