Sickle Cell Disease (SCD)Phase 2STEADFASTNCT04053764
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
A Phase 2 study testing Crizanlizuamb in people with Sickle Cell Disease (SCD), run by Novartis Pharmaceuticals at 24 sites in 11 countries.
Trial summary
The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease (SCD)
- What is being tested?
- Crizanlizuamb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 24 sitesin 11 countries
- Study dates
- 10 Dec 2019to 20 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
- Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients < 18)
- Patients with ACR of ≥ 100 to < 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
- Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months.
- Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, and platelet count ≥ 75 x 10^9/L
- Adequate hepatic function as defined by:
Show all 9Show fewer
- Alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN)
- Direct (conjugated) bilirubin ≤ 3.0 x ULN
- Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Who cannot join
- History of stem cell transplant
- Patients with evidence of AKI within 3 months of study entry (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry)
- Blood pressure > 140/90 mmHg despite treatment
- Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation)
- Received blood products within 30 days of Week 1 Day 1
- Participating in a chronic transfusion program
Show all 11Show fewer
- History of kidney transplant
- Patients with hypoalbuminemia
- Body mass index of ≥ 35
- Currently receiving or received voxelotor within 6 months of screening
- Patient has received crizanlizumab and/or other selectin inhibitor or plans to receive it during the duration of the study.
Trial locations and contacts
24 sites in 11 countries.
24 sites in 11 countries
United States6 sites
Our Lady of the Lake Regional Medic .
Baton Rouge, Louisiana, 70809
University of Alabama Birmingham
Birmingham, Alabama, 35233
University of Illinois Hospital and Health Sciences System .
Chicago, Illinois, 60612
East Carolina University BrodySchool of Med 3
Greenville, North Carolina, 27858
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Univ of Tenn Health Sciences Ctr
Memphis, Tennessee, 38163
Brazil3 sites
Novartis Investigative Site
Porto Alegre, 90035-003
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20.211-030
Novartis Investigative Site
São Paulo, São Paulo, 01232-010
Turkey (Türkiye)3 sites
Novartis Investigative Site
Adana, 01250
Novartis Investigative Site
Adana, 01330
Novartis Investigative Site
Antakya / Hatay, 31100
United Kingdom3 sites
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
London, W12 0HS
France2 sites
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Paris, 75015
Greece2 sites
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Larissa, 41221
About this study
Official title: A Phase II, Multicenter, Randomized, Open Label Two Arm Study Evaluating the Effect of Crizanlizumab + Standard of Care and Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy (STEADFAST)
The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Read the detailed description
Approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. Patients were stratified at randomization based on chronic kidney disease (CKD) risk category (moderate risk or high/very high risk) and hydroxyurea/hydroxycarbamide (HU/HC) prescription (Yes/No). The CKD risk categories used for stratification were based on both Estimated glomerular filtration rate(eGFR) and albuminuria assessed by Albumin/creatinine ratio (ACR).
- Conditions
- Sickle Cell Disease (SCD)
- Being tested
- Crizanlizuamb, Standard of Care
- Keywords
- SEG101, Sickle Cell Disease, SCD, Crizanlizumab, Sickle cell nephropathy, chronic kidney disease, CKD, albuminuria (ACR), renal function, standard of care
- Medical subject headings
- Anemia, Sickle Cell, Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrizanlizuambDrug
Also called SEG101
Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
Standard of CareDrug
HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker)
| Study group | Role | What they receive |
|---|---|---|
| crizanlizumab + standard of care | Experimental | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. Receives: Drug: Crizanlizuamb; Drug: Standard of Care |
| standard of care | Active comparator | Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.
Measured: Baseline to 12 months
Secondary outcomes (11)
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
The effect of SEG101 on clinical disease activity was measured by the change in albuminuria (ACR) between baseline and month 3, baseline and month 6, baseline and month 9, baseline and month 12. A reduction from baseline indicates improvement in patients.
Measured: Baseline to 3, 6, 9, and 12 months
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 6. A reduction from baseline indicates improvement in patients.
Measured: Baseline to 6 months
Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months
The effect of SEG101 on clinical disease activity was measured by counting patients who had Stable PCR: within ± 20% change from baseline to month 12. PCR improvement: ≥ 20% decrease in PCR from baseline indicates improvement in patients.
Measured: Baseline to 12 months
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
The percentage change in eGFR was calculated as the post-baseline eGFR value minus the baseline eGFR divided by the eGFR at baseline. A reduction from baseline indicates improvement in participants.
Measured: Baseline to 3, 6, 9, and 12 months
Slope of Albumin to Creatinine Ratio (ACR) Decline
The effect of SEG101 on clinical disease activity was measured by the slope of ACR decline between baseline and Month 12. A reduction from baseline indicates improvement in patients.
Measured: Baseline to 12 months
Slope of Estimated Glomerular Filtration Rate (eGFR) Decline
The effect of SEG101 on clinical disease activity was measured by the slope of eGFR between baseline and Month 12. The calculation of eGFR is based on the chronic kidney disease epidemiology collaboration (CKD-EPI) (for patients ≥ 18) and Creatinine-based "Bedside Schwartz" (for patients < 18) equations. A reduction in drop rate from baseline indicates improvement in patients.
Measured: Baseline to 12 months
Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months
The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in participants.
CKD progression is defined as an increase in CKD progression category, a 25% or greater drop in eGFR from baseline or at least 50% increase in ACR for patients with severe (A3) albuminuria and a doubling of albumin levels in patients with moderate (A2) albuminuria.
Measured: Baseline to 12 months
Shift Table for Chronic Kidney Disease (CKD) Progression
The effect of SEG101 on clinical disease activity was measured by percentage of participants with CKD progression between baseline and Month 12. A reduction from baseline indicates improvement in patients.
Measured: Baseline and month 12
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
The effect of SEG101 on clinical disease activity was measured by percentage of participants shifted to different worst post-baseline categories between baseline and Month 12. An increase in percentage shifting from higher category to lower category indicates improvement in patients.
Baseline is defined as the last non-missing value prior to the first dose.
Measured: Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months
Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations
The effect of SEG101 on clinical disease activity was measured by summarizing the annualized rate of visits to ER and hospitalizations between baseline and 1 year 4 months. Annualized rate of hospitalizations and ER visits due to VOC =(Number of ER or hospitalizations reported until End date x 365.25)/(End date-date of first dose of study treatment+1). A reduction from baseline indicates improvement in patients.
Measured: Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months
Mean Serum Concentration (Ctrough) of Crizanlizumab
The effect of SEG101 on clinical disease activity was measured by checking the concentration of the Drug in serum at different time points.
Crizanlizumab pre-dose/trough pharmacokinetic samples were taken at select time points.
Measured: Pre-dose and 336 hours post-dose on Week 3 Day 1; pre-dose and 672 hours post dose on Week 11 Day 1, Week 23 Day 1 and Week 39 Day 1; and 672 hours post dose on Week 53 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start10 Dec 2019
- Primary completion20 Mar 2023
- Study completion20 Mar 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Disease (SCD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053764
- Sponsor's protocol ID
- CSEG101A2203
- Other IDs
- 2018-003608-38, 2018
- Acronym
- STEADFAST
- Status last verified
- Oct 2024
- First submitted
- 9 Aug 2019
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Publications
Abbasi M, Srivastava A, Saraf SL. Management of Kidney Disease with Sickle Cell Disease. J Am Soc Nephrol. 2025 Oct 1;36(10):2041-2054. doi: 10.1681/ASN.0000000804. Epub 2025 Jun 26.
PubMed 40569673Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
PubMed 37254256
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Open Label Two Arm Study Evaluating the Effect of Crizanlizumab + Standard of Care and Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy (STEADFAST)
- ClinicalTrials.gov ID
- NCT04053764
- Acronym / sponsor ID
- STEADFAST / CSEG101A2203
- Conditions
- Sickle Cell Disease (SCD)
- Keywords
- SEG101, Sickle Cell Disease, SCD, Crizanlizumab, Sickle cell nephropathy, chronic kidney disease, CKD, albuminuria (ACR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Posted 4 Jun 2024
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 the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Detailed description
Approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. Patients were stratified at randomization based on chronic kidney disease (CKD) risk category (moderate risk or high/very high risk) and hydroxyurea/hydroxycarbamide (HU/HC) prescription (Yes/No). The CKD risk categories used for stratification were based on both Estimated glomerular filtration rate(eGFR) and albuminuria assessed by Albumin/creatinine ratio (ACR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crizanlizumab + standard of care | Experimental | Drug: Crizanlizuamb, Drug: Standard of Care5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. |
| standard of care | Active comparator | Drug: Standard of CarePatients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
- Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients < 18)
- Patients with ACR of ≥ 100 to < 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
- Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months.
- Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, and platelet count ≥ 75 x 10^9/L
Key exclusion criteria (11 listed)
- History of stem cell transplant
- Patients with evidence of AKI within 3 months of study entry (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry)
- Blood pressure > 140/90 mmHg despite treatment
- Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation)
- Received blood products within 30 days of Week 1 Day 1
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 |
|---|---|---|
| CrizanlizuambAlso: SEG101Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab | Drug | crizanlizumab + standard of care |
| Standard of CareHU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker) | Drug | crizanlizumab + standard of care, standard of care |
Primary outcome
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months
Time frame: Baseline to 12 months
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.
11 secondary outcomes
Change From Baseline in Albuminuria (ACR) at 3, 6, 9 and 12 Months
Time frame: Baseline to 3, 6, 9, and 12 months
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 6 Months
Time frame: Baseline to 6 months
Percentage of Participants With Protein/Creatinine Ratio (PCR) Improvement and Stable PCR at 12 Months
Time frame: Baseline to 12 months
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline to 3, 6, 9, and 12 months
Slope of Albumin to Creatinine Ratio (ACR) Decline
Time frame: Baseline to 12 months
Slope of Estimated Glomerular Filtration Rate (eGFR) Decline
Time frame: Baseline to 12 months
Percentage of Participants With Progression of Chronic Kidney Disease (CKD) at 12 Months
Time frame: Baseline to 12 months
Shift Table for Chronic Kidney Disease (CKD) Progression
Time frame: Baseline and month 12
Immunogenicity: Percentage of Participants With Anti-drug Antibodies (ADA) to Crizanlizumab
Time frame: Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months
Annualized Rate of Visits to Emergency Room (ER) and Hospitalizations
Time frame: Baseline to follow-up period (at select time points), assessed up to approximately 1 year and 4 months
Mean Serum Concentration (Ctrough) of Crizanlizumab
Time frame: Pre-dose and 336 hours post-dose on Week 3 Day 1; pre-dose and 672 hours post dose on Week 11 Day 1, Week 23 Day 1 and Week 39 Day 1; and 672 hours post dose on Week 53 Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40569673Abbasi M, Srivastava A, Saraf SL. Management of Kidney Disease with Sickle Cell Disease. J Am Soc Nephrol. 2025 Oct 1;36(10):2041-2054. doi: 10.1681/ASN.0000000804. Epub 2025 Jun 26.
- Derived from this study: PubMed 37254256Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
24 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crizanlizuamb in people with Sickle Cell Disease (SCD), run by Novartis Pharmaceuticals at 24 sites in 11 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 9 inclusion and 11 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Brazil, Turkey (Türkiye), United Kingdom, France and 6 more countries. 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 4 Jun 2024). 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?
Percentage of Participants With ≥ 30% Decrease in Albuminuria (ACR) at 12 Months (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053764, which also lists 2 linked publications.
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 9 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.