Chronic Kidney DiseasePhase 1NCT07901933
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
A Phase 1 study testing CTX001 and Ferrous Sulfate in people with Chronic Kidney Disease and Anemia, run by Cajal Therapeutics Inc. at 4 sites in Australia.
Trial summary
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Anemia
- What is being tested?
- CTX001 and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesAustralia
- Study dates
- Nov 2026to Nov 2027
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years of age
- Body mass index (BMI) between 18 and 35 kg/m2
- Estimated GFR ≥15 and <60 mL/min/1.73 m2
- CKD for at least 3 months
- Not currently receiving dialysis and not expected to start dialysis within 3 months of screening.
- Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL
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- Transferrin saturation (TSAT) ≤20%
- Not folate or vitamin B12 deficient
- ALT and AST ≤1.5 x ULN and TBL ≤1.5 x ULN
Who cannot join
- Anemia due to a cause other than CKD, presence of active bleeding, or recent significant blood loss
- Any hemoglobinopathy, bone marrow pathology or hematological malignancy, including, but not limited to sickle cell disease, thalassemia, myelodysplastic syndrome, bone marrow fibrosis, red cell aplasia
- Known history of hemochromatosis or other iron-overload disorder, or ferritin >700 ng/mL
- RBC transfusion, intravenous iron, or ESA use within 12 weeks prior to screening
- Receiving an SGLT2 inhibitor on a dose that has not been stable for at least 12 weeks prior to screening.
- Pregnant or breastfeeding.
Show all 9Show fewer
- Is unable or unwilling to comply with protocol-specified sun protection and contraception requirements.
- Has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Has a concurrent disease or condition or physical, psychological, mental, and/or social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites
Renal Research Gosford
Gosford, New South Wales, 2250
Nikki Paine, +61 2 4323 7977, nikki@renalresearch.com.au
Tracey Seiffert, tracey@renalresearch.com.au
Royal Perth Hospital
Perth, Western Australia, 6000
Anu Joyson, +61 8 9224 0390, anu.joyson@uwa.edu.au
Dr Hemant Kulkarni
AOVO Clinical Trials
Southport, Queensland, 4215
Judy Coote, +61 7 5532 0877 ext. 214, judy.coote@aovo.com.au
Dr Ellen Hourn
Royal North Shore Hospital
St Leonards, New South Wales, 2065
A/Prof Brendon Neuen, +61 2 9462 9655, brendon.neuen@health.nsw.gov.au
Rebecca Stevenson, +61 2 9462 9655, Rebecca.Stevenson@health.nsw.gov.au
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis.
Read the detailed description
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis. The primary objective is to assess the preliminary safety and tolerability of CTX001 administered with iron in this patient population. Secondary objectives include assessment of concentrations of CTX001 in the blood at different dose levels, and the impact of administration of CTX001 with iron on blood iron levels and other hematologic parameters.
Up to 2 different doses of CTX001 are planned to be tested in cohorts of 12 participants each, for a total planned enrollment of up to 24 participants. An additional group of up to 12 participants may be enrolled to evaluate an additional dose level. Eligible participants will be randomly assigned in a 3:1 ratio to receive CTX001 or placebo, together with an oral iron supplement, for 29 days.
- Conditions
- Chronic Kidney Disease, Anemia
- Being tested
- Placebo, CTX001, Ferrous Sulfate
- Keywords
- Anemia, NDD CKD, CKD, Non-dialysis dependent chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo administered orally once daily for 29 days.
CTX001Drug
CTX001 administered orally at the assigned cohort dose once daily for 29 days.
Ferrous SulfateDrug
Ferrous sulfate administered orally once daily for 29 days in both treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| CTX001 plus oral iron | Experimental | Participants receive CTX001 at the assigned cohort dose together with oral iron once daily for 29 days. Receives: Drug: CTX001; Drug: Ferrous Sulfate |
| Placebo plus oral iron | Placebo comparator | Participants receive matching placebo together with oral iron once daily for 29 days. Receives: Drug: Placebo; Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants with at least one (TEAE). An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to the study intervention. An AE is considered a treatment-emergent AE (TEAE) if the AE begins or worsens after the first dose of study intervention and on or before the last study visit.
Measured: From first administration of study intervention through the end of study participation, around Day 36.
Incidence of Serious TEAEs
Number and percentage of participants with at least one serious treatment-emergent adverse event (TEAE). A serious AE (SAE) is defined as any AE that, at any dose, meets one or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital anomaly or birth defect; or any important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
Measured: From first administration of study intervention through the end of study participation, around Day 36.
Incidence of Clinically Significant Changes in Physical Examination
The investigator assesses the clinical significance of changes in physical examination findings.
Measured: From first administration of study intervention through the end of study participation, around Day 36.
Incidence of Clinically Significant Changes in Safety Laboratory Values
Safety laboratory evaluations include blood counts, serum chemistries, coagulation studies and urinalyses. Determination of clinical significance is based on investigator discretion.
Measured: From first administration of study intervention through the end of study participation, around Day 36.
Incidence of Clinically Significant Changes in Vital Signs
Vital signs include heart rate, respiratory rate, blood pressure, and temperature. Determination of clinical significance is based on investigator discretion.
Measured: From first administration of study intervention through the end of study participation, around Day 36
Incidence of Clinically Significant Changes in Electrocardiograms
Electrocardiograms are tests that measure the electrical activity of the heart. Determination of clinical significance is based on investigator discretion.
Measured: From first administration of study intervention through the end of study participation, around Day 36
Secondary outcomes (17)
Maximum Change From Baseline in Hemoglobin
Maximum observed change from baseline in hemoglobin concentration.
Measured: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change From Baseline in Hematocrit
Maximum observed change from baseline in hematocrit.
Measured: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change from Baseline in Serum Iron
Measured: Baseline through the end of the treatment period, around Day 29
Maximum Change from Baseline in Ferritin
Measured: Baseline through the end of the treatment period, around Day 29
Maximum Change from Baseline in Transferrin Saturation
Measured: Baseline through the end of the treatment period, around Day 29
Maximum Change from Baseline in Transferrin
Measured: Baseline through the end of the treatment period, around Day 29.
Maximum Change from Baseline in Reticulocyte Count
Measured: From first administration of study intervention through the end of study participation, around Day 36.
Maximum Change from Baseline in Red Blood Cell (RBC) Count
Measured: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change from Baseline in Mean Corpuscular Hemoglobin
Measured: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change From Baseline in Reticulocyte Hemoglobin Content
Measured: From first administration of study intervention through the end of study participation, around Day 36
Plasma Concentrations of CTX001
Plasma concentrations of CTX001 by dose level over time.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Maximum Observed Plasma Concentration of CTX001 (Cmax)
The highest observed plasma concentration of CTX001 following dosing.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Time to Maximum Observed Plasma Concentration of CTX001 (Tmax)
Time from dosing to the maximum observed plasma concentration of CTX001.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Area Under the Plasma Concentration-Time Curve of CTX001 From Time 0 to the Last Quantifiable Concentration (AUC0-t)
Area under the CTX001 plasma concentration-time curve from dosing to the time of the last quantifiable concentration.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Area Under the Plasma Concentration-Time Curve of CTX001 Extrapolated to Infinity (AUC∞)
Area under the CTX001 plasma concentration-time curve from dosing extrapolated to infinity, where reliably estimable.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Apparent Oral Clearance of CTX001 (CL/F)
Apparent oral clearance of CTX001, estimated from the administered dose and plasma concentration-time data, where reliably estimable.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Terminal Elimination Half-Life of CTX001 (t½)
Time required for the plasma concentration of CTX001 to decrease by half during the terminal elimination phase, where reliably estimable.
Measured: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cajal Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901933
- Sponsor's protocol ID
- CTX001-102
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07901933
- Acronym / sponsor ID
- CTX001-102
- Conditions
- Chronic Kidney Disease, Anemia
- Keywords
- Anemia, NDD CKD, CKD, Non-dialysis dependent chronic kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cajal Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 Oct 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.
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis.
Detailed description
This is a Phase 1b, randomized, double-blinded, placebo-controlled study of CTX001 in participants with anemia and chronic kidney disease who are not on dialysis. The primary objective is to assess the preliminary safety and tolerability of CTX001 administered with iron in this patient population. Secondary objectives include assessment of concentrations of CTX001 in the blood at different dose levels, and the impact of administration of CTX001 with iron on blood iron levels and other hematologic parameters.
Up to 2 different doses of CTX001 are planned to be tested in cohorts of 12 participants each, for a total planned enrollment of up to 24 participants. An additional group of up to 12 participants may be enrolled to evaluate an additional dose level. Eligible participants will be randomly assigned in a 3:1 ratio to receive CTX001 or placebo, together with an oral iron supplement, for 29 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTX001 plus oral iron | Experimental | Drug: CTX001, Drug: Ferrous SulfateParticipants receive CTX001 at the assigned cohort dose together with oral iron once daily for 29 days. |
| Placebo plus oral iron | Placebo comparator | Drug: Placebo, Drug: Ferrous SulfateParticipants receive matching placebo together with oral iron once daily for 29 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18 and 75 years of age
- Body mass index (BMI) between 18 and 35 kg/m2
- Estimated GFR ≥15 and <60 mL/min/1.73 m2
- CKD for at least 3 months
- Not currently receiving dialysis and not expected to start dialysis within 3 months of screening.
Key exclusion criteria (9 listed)
- Anemia due to a cause other than CKD, presence of active bleeding, or recent significant blood loss
- Any hemoglobinopathy, bone marrow pathology or hematological malignancy, including, but not limited to sickle cell disease, thalassemia, myelodysplastic syndrome, bone marrow fibrosis, red cell aplasia
- Known history of hemochromatosis or other iron-overload disorder, or ferritin >700 ng/mL
- RBC transfusion, intravenous iron, or ESA use within 12 weeks prior to screening
- Receiving an SGLT2 inhibitor on a dose that has not been stable for at least 12 weeks prior to screening.
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 |
|---|---|---|
| PlaceboMatching placebo administered orally once daily for 29 days. | Drug | Placebo plus oral iron |
| CTX001CTX001 administered orally at the assigned cohort dose once daily for 29 days. | Drug | CTX001 plus oral iron |
| Ferrous SulfateFerrous sulfate administered orally once daily for 29 days in both treatment arms. | Drug | CTX001 plus oral iron, Placebo plus oral iron |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first administration of study intervention through the end of study participation, around Day 36.
Number and percentage of participants with at least one (TEAE). An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to the study intervention. An AE is considered a treatment-emergent AE (TEAE) if the AE begins or worsens after the first dose of study intervention and on or before the last study visit.
Incidence of Serious TEAEs
Time frame: From first administration of study intervention through the end of study participation, around Day 36.
Number and percentage of participants with at least one serious treatment-emergent adverse event (TEAE). A serious AE (SAE) is defined as any AE that, at any dose, meets one or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital anomaly or birth defect; or any important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
Incidence of Clinically Significant Changes in Physical Examination
Time frame: From first administration of study intervention through the end of study participation, around Day 36.
The investigator assesses the clinical significance of changes in physical examination findings.
Incidence of Clinically Significant Changes in Safety Laboratory Values
Time frame: From first administration of study intervention through the end of study participation, around Day 36.
Safety laboratory evaluations include blood counts, serum chemistries, coagulation studies and urinalyses. Determination of clinical significance is based on investigator discretion.
Incidence of Clinically Significant Changes in Vital Signs
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Vital signs include heart rate, respiratory rate, blood pressure, and temperature. Determination of clinical significance is based on investigator discretion.
Incidence of Clinically Significant Changes in Electrocardiograms
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Electrocardiograms are tests that measure the electrical activity of the heart. Determination of clinical significance is based on investigator discretion.
17 secondary outcomes
Maximum Change From Baseline in Hemoglobin
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change From Baseline in Hematocrit
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change from Baseline in Serum Iron
Time frame: Baseline through the end of the treatment period, around Day 29
Maximum Change from Baseline in Ferritin
Time frame: Baseline through the end of the treatment period, around Day 29
Maximum Change from Baseline in Transferrin Saturation
Time frame: Baseline through the end of the treatment period, around Day 29
Maximum Change from Baseline in Transferrin
Time frame: Baseline through the end of the treatment period, around Day 29.
Maximum Change from Baseline in Reticulocyte Count
Time frame: From first administration of study intervention through the end of study participation, around Day 36.
Maximum Change from Baseline in Red Blood Cell (RBC) Count
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change from Baseline in Mean Corpuscular Hemoglobin
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Maximum Change From Baseline in Reticulocyte Hemoglobin Content
Time frame: From first administration of study intervention through the end of study participation, around Day 36
Plasma Concentrations of CTX001
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Maximum Observed Plasma Concentration of CTX001 (Cmax)
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Time to Maximum Observed Plasma Concentration of CTX001 (Tmax)
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Area Under the Plasma Concentration-Time Curve of CTX001 From Time 0 to the Last Quantifiable Concentration (AUC0-t)
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Area Under the Plasma Concentration-Time Curve of CTX001 Extrapolated to Infinity (AUC∞)
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Apparent Oral Clearance of CTX001 (CL/F)
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
Terminal Elimination Half-Life of CTX001 (t½)
Time frame: Pre-dose through the end of the pharmacokinetic sampling period. Days 1, 15, and 29; pre-dose and 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post-dose.
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 28 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.
4 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 CTX001 and Ferrous Sulfate in people with Chronic Kidney Disease and Anemia, run by Cajal Therapeutics Inc. at 4 sites in Australia.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 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 4 sites in Australia. 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. Some participants in this study may receive a placebo. 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?
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?
Contact A/Prof. Brendon Neuen (+61 2 9462 9655, brendon.neuen@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first administration of study intervention through the end of study participation, around Day 36.). The study lists 6 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 28 Oct 2026.