Type 2 Diabetes MellitusPhase 4ROCKIESNCT04027530
Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study.
A Phase 4 study testing Ertugliflozin 15 mg in people with Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Diabetic Nephropathy
- What is being tested?
- Ertugliflozin 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2020to 9 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as no menses >1 year and follicle stimulating hormone (FSH) >31 U/L)*.
- Type 2 diabetes mellitus since at least 3 years with HbA1c ≥ 6.5% (≥57mmol/mol) and <10% (<94mmol/mol)
- An appropriate stable dose of metformin and/or sulfonylurea as glucose-lowering therapy for the last 12 weeks
- Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization.
- eGFR 60-90 ml/min/1.73m²
- BMI 25-35 kg/m² * In order to increase homogeneity
Who cannot join
- Involvement in the planning and/or conduction of another study
- Participation in another clinical study with an investigational product during the last 3 months
- Diagnosis of type 1 diabetes mellitus
- CKD defined as eGFR<60 ml/min/1.73m² or albuminuria (defined as an UACR > 2.5 mg/mol).
- Cardiovascular disease event in the last 6 months prior to enrollment as assessed by the investigator, including: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
- Current/chronic use of the following medication: insulin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, oral glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs), diuretics, and monoamine oxidase inhibitors.
Show all 23Show fewer
- Current urinary tract infection or active nephritis
- History of ketoacidosis
- History of allergy/hypersensitivity to any of the test agents.
- Group 2: Age-matched and eGFR-matched non-diabetic controls Inclusion criteria
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as no menses >1 year and follicle stimulating hormone (FSH) >31 U/L)*.
- Normal glucose tolerance at screening as confirmed by OGTT
- Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization in case of hypertension.
- BMI 25-35 kg/m2
- eGFR 60-90ml/min * In order to increase homogeneity
- Involvement in the planning and/or conduction of another study
- Participation in another clinical study with an investigational product during the last 3 months
- CKD defined as eGFR<60ml/min or macro-albuminuria or proteinuria
- Cardiovascular disease event in the last 6 months prior to enrollment, as assessed by the investigator, including: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
- Use of medication that may interfere with study endpoints non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs), diuretics, and monoamine oxidase inhibitors.
- Current urinary tract infection and active nephritis
- Any other condition that prevents participation as judged by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4, Randomized, Placebo-controlled, Cross-over Trial to Assess the Effect of 4-week Ertugliflozin (SGLT-2 Inhibitor) Therapy on Renal Oxygenation by BOLD-MRI and Renal Oxygen Consumption by PET Using ¹¹C-acetate in T2DM Without Kidney Disease and Healthy Controls.
Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Moreover, this research will focus on the effects of sodium-glucose cotransporter 2 inhibition on renal tissue oxygenation and oxygen consumption as well as a change in intrarenal hemodynamics and perfusion, and a shift of fuel metabolites. Elucidation the mechanisms underlying the effects of SGLT2 inhibition will advance our knowledge and contribute to their optimal clinical utilization in the treatment of chronic kidney disease in diabetes and possibly beyond.
Read the detailed description
Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) are a relatively new class of drugs in the treatment of diabetes and improve glycemic control by blocking SGLT-2 in the proximal tubule, the main transporter of coupled sodium-glucose reabsorption Three large cardiovascular outcome trials (EMPA-REG, CANVAS, DECLARE- TIMI 58) showed SGLT-2 inhibition to have a renoprotective effect, including on renal outcomes. Moreover, the recently publicized CREDENCE trial concluded early after the planned interim analyses showed a striking renoprotective effect of SGLT-2 inhibition in patients with T2DM and CKD. The mechanisms underlying their beneficial effects remain to be elucidated, as the small SGLT-2 induced reduction in glucose level (0.5% HbA1c), bodyweight (about 3%), systolic blood pressure (about 4 mmHg), or uric acid (about 6%) are insufficient to fully account for the effect.
The pathological mechanisms underlying DKD involve complex interactions between metabolic and haemodynamic factors which are not fully understood. However, accumulating evidence of foremost animal studies indicates that a chronic state of renal tissue hypoxia is the final common pathway in the development and progression of diabetic kidney disease. Therefore several hypothesis have been proposed on the alleviation of chronic tissue hypoxia following SGLT-2 inhibition: (1) A decrease in workload by a decrease in GFR. (2) A shift in renal fuel energetics by increasing ketone body oxidation, which renders high ATP/oxygen consumption ratio's compared to glucose or free fatty acids. (3) An improvement of cardiac function and systemic hemodynamics to lead to an increase in renal perfusion, and (4) an increase in erythropoietin (EPO) levels to stimulate oxygen delivery.
Current study will examine the above hypothesis by researching renal oxygenation by BOLD-MRI, oxygen consumption by PET-CT, and hemodynamic kinetics by the Iohexol clearance method/contrast-enhance ultrasound/arterial spin labeling. Blood sampling will allow for the measurement of EPO and ketone bodies, as well as a resting energy expenditure will elucidate a shift in use of energy substrate metabolism. The research will be performed in T2DM without overt kidney disease (n=20) before and after a 4 week treatment with SGLT-2 inhibition (ertugliflozin), and will be compared the obtained results from healthy controls (n=20).
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Diabetic Nephropathy, Renal Hypoxia, Renoprotection, SGLT2 Inhibitor
- Being tested
- Ertugliflozin 15 mg
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertugliflozin 15 mgDrug
Also called Steglatro
Once daily treatment with oral ertugliflozin 15mg for 4 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Ertugliflozin 15mg once daily | Experimental | Once daily treatment with oral ertugliflozin (steglatro) 15mg for 4 consecutive weeks. Receives: Drug: Ertugliflozin 15 mg |
| Placebo | Placebo comparator | Once daily treatment with a placebo pill for 4 consecutive weeks. Receives: Drug: Ertugliflozin 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal oxygenation measured by BOLD-MRI (R2*)
Renal (separated as cortical and medullar) oxygenation measured by BOLD-MRI (R2*)
Measured: After 4 week treatment with ertugliflozin 15mg QD versus placebo
Secondary outcomes (21)
Renal oxygen consumption by PET/CT-scan using 11C-Acetate
Renal oxygen consumption will be measured by PET/CT-scan using 11C-Acetate and compartment model parameter k2
Measured: After 4 week treatment with active drug intervention versus placebo
Renal hemodynamics
GFR and ERPF
Measured: After 4 week treatment with active drug intervention versus placebo
Renal efficiency
Measured as sodium reabsorption divided by oxygen consumption
Measured: After 4 week treatment with active drug intervention versus placebo
Cortical blood flow
measured by contrast-enhanced ultrasound
Measured: After 4 week treatment with active drug intervention versus placebo
Renal arterial blood flow
measured by arterial spin labelling
Measured: After 4 week treatment with active drug intervention versus placebo
Acute 24-hour sodium and glucose excretion
24-hour sodium and glucose excretion after 2 days
- Urine osmolality
- Urinary pH
Measured: After 2 days of treatment with active drug intervention versus placebo
Chronic 24-hour sodium and glucose excretion
24-hour sodium and glucose excretion after 4 weeks
Measured: After 4 week treatment with active drug intervention versus placebo
Renal tubular function: Urinary pH
Urinary pH
Measured: After 4 week treatment with active drug intervention versus placebo
Renal tubular function: Urine Osmolality
Urine osmolality
Measured: After 4 week treatment with active drug intervention versus placebo
Renal tubular function: sodium transport
Iohexol corrected sodium excretion
Measured: After 4 week treatment with active drug intervention versus placebo
Renal damage markers
Renal damage markers will include: urinary albumin excretion in 24-hour urine samples and other markers depending on relevant (emerging) metabolic and humoral biomarkers of renal damage, conditional to available budget.
Measured: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate: glucose
Changes in plasma energy substrate: glucose
Measured: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate: free fatty acids
Changes in plasma energy substrate: free fatty acids
Measured: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate: ketone bodies
Changes in plasma energy substrate: ketone bodies
Measured: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate:triglycerides
Changes in plasma energy substrate:triglycerides
Measured: After 4 week treatment with active drug intervention versus placebo
Energy expenditure
By resting energy expenditure
Measured: After 4 week treatment with active drug intervention versus placebo
Changes in erythropoietin (EPO) levels
Changes in erythropoietin (EPO) levels
Measured: After 4 week treatment with active drug intervention versus placebo
Insulin sensitivity
OGIS and Matsuda Index during an oral glucose tolerance test (OGTT)
Measured: After 4 week treatment with active drug intervention versus placebo
Beta-cell function
Beta-cell function will be derived from HOMA-B modelling during an oral glucose tolerance test (OGTT).
Measured: After 4 week treatment with active drug intervention versus placebo
Peripheral insulin extraction
Arterial-venous difference before and following an OGTT
Measured: After 4 week treatment with active drug intervention versus placebo
Total insulin extraction
Arterial-venous difference before and following an OGTT
Measured: After 4 week treatment with active drug intervention versus placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start10 Dec 2020
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D van Raalte, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027530
- Sponsor's protocol ID
- DC2019 ROCKIES 1
- Acronym
- ROCKIES
- Status last verified
- Apr 2023
- First submitted
- 9 Jul 2019
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Randomized, Placebo-controlled, Cross-over Trial to Assess the Effect of 4-week Ertugliflozin (SGLT-2 Inhibitor) Therapy on Renal Oxygenation by BOLD-MRI and Renal Oxygen Consumption by PET Using ¹¹C-acetate in T2DM Without Kidney Disease and Healthy Controls.
- ClinicalTrials.gov ID
- NCT04027530
- Acronym / sponsor ID
- ROCKIES / DC2019 ROCKIES 1
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Diabetic Nephropathy, Renal Hypoxia, Renoprotection, SGLT2 Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 22 Jul 2019 (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.
Current study will render insight in to the role of renal hypoxia in the diabetic kidney and is able to associate its finding with measurements of renal perfusion and glomerular filtration rate. Moreover, this research will focus on the effects of sodium-glucose cotransporter 2 inhibition on renal tissue oxygenation and oxygen consumption as well as a change in intrarenal hemodynamics and perfusion, and a shift of fuel metabolites. Elucidation the mechanisms underlying the effects of SGLT2 inhibition will advance our knowledge and contribute to their optimal clinical utilization in the treatment of chronic kidney disease in diabetes and possibly beyond.
Detailed description
Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) are a relatively new class of drugs in the treatment of diabetes and improve glycemic control by blocking SGLT-2 in the proximal tubule, the main transporter of coupled sodium-glucose reabsorption Three large cardiovascular outcome trials (EMPA-REG, CANVAS, DECLARE- TIMI 58) showed SGLT-2 inhibition to have a renoprotective effect, including on renal outcomes. Moreover, the recently publicized CREDENCE trial concluded early after the planned interim analyses showed a striking renoprotective effect of SGLT-2 inhibition in patients with T2DM and CKD. The mechanisms underlying their beneficial effects remain to be elucidated, as the small SGLT-2 induced reduction in glucose level (0.5% HbA1c), bodyweight (about 3%), systolic blood pressure (about 4 mmHg), or uric acid (about 6%) are insufficient to fully account for the effect.
The pathological mechanisms underlying DKD involve complex interactions between metabolic and haemodynamic factors which are not fully understood. However, accumulating evidence of foremost animal studies indicates that a chronic state of renal tissue hypoxia is the final common pathway in the development and progression of diabetic kidney disease. Therefore several hypothesis have been proposed on the alleviation of chronic tissue hypoxia following SGLT-2 inhibition: (1) A decrease in workload by a decrease in GFR. (2) A shift in renal fuel energetics by increasing ketone body oxidation, which renders high ATP/oxygen consumption ratio's compared to glucose or free fatty acids. (3) An improvement of cardiac function and systemic hemodynamics to lead to an increase in renal perfusion, and (4) an increase in erythropoietin (EPO) levels to stimulate oxygen delivery.
Current study will examine the above hypothesis by researching renal oxygenation by BOLD-MRI, oxygen consumption by PET-CT, and hemodynamic kinetics by the Iohexol clearance method/contrast-enhance ultrasound/arterial spin labeling. Blood sampling will allow for the measurement of EPO and ketone bodies, as well as a resting energy expenditure will elucidate a shift in use of energy substrate metabolism. The research will be performed in T2DM without overt kidney disease (n=20) before and after a 4 week treatment with SGLT-2 inhibition (ertugliflozin), and will be compared the obtained results from healthy controls (n=20).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertugliflozin 15mg once daily | Experimental | Drug: Ertugliflozin 15 mgOnce daily treatment with oral ertugliflozin (steglatro) 15mg for 4 consecutive weeks. |
| Placebo | Placebo comparator | Drug: Ertugliflozin 15 mgOnce daily treatment with a placebo pill for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as no menses >1 year and follicle stimulating hormone (FSH) >31 U/L)*.
- Type 2 diabetes mellitus since at least 3 years with HbA1c ≥ 6.5% (≥57mmol/mol) and <10% (<94mmol/mol)
- An appropriate stable dose of metformin and/or sulfonylurea as glucose-lowering therapy for the last 12 weeks
- Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization.
Key exclusion criteria (23 listed)
- Involvement in the planning and/or conduction of another study
- Participation in another clinical study with an investigational product during the last 3 months
- Diagnosis of type 1 diabetes mellitus
- CKD defined as eGFR<60 ml/min/1.73m² or albuminuria (defined as an UACR > 2.5 mg/mol).
- Cardiovascular disease event in the last 6 months prior to enrollment as assessed by the investigator, including: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
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 |
|---|---|---|
| Ertugliflozin 15 mgAlso: SteglatroOnce daily treatment with oral ertugliflozin 15mg for 4 consecutive weeks | Drug | Ertugliflozin 15mg once daily, Placebo |
Primary outcome
Renal oxygenation measured by BOLD-MRI (R2*)
Time frame: After 4 week treatment with ertugliflozin 15mg QD versus placebo
Renal (separated as cortical and medullar) oxygenation measured by BOLD-MRI (R2*)
21 secondary outcomes
Renal oxygen consumption by PET/CT-scan using 11C-Acetate
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal hemodynamics
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal efficiency
Time frame: After 4 week treatment with active drug intervention versus placebo
Cortical blood flow
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal arterial blood flow
Time frame: After 4 week treatment with active drug intervention versus placebo
Acute 24-hour sodium and glucose excretion
Time frame: After 2 days of treatment with active drug intervention versus placebo
Chronic 24-hour sodium and glucose excretion
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal tubular function: Urinary pH
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal tubular function: Urine Osmolality
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal tubular function: sodium transport
Time frame: After 4 week treatment with active drug intervention versus placebo
Renal damage markers
Time frame: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate: glucose
Time frame: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate: free fatty acids
Time frame: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate: ketone bodies
Time frame: After 4 week treatment with active drug intervention versus placebo
Changes in plasma energy substrate:triglycerides
Time frame: After 4 week treatment with active drug intervention versus placebo
Energy expenditure
Time frame: After 4 week treatment with active drug intervention versus placebo
Changes in erythropoietin (EPO) levels
Time frame: After 4 week treatment with active drug intervention versus placebo
Insulin sensitivity
Time frame: After 4 week treatment with active drug intervention versus placebo
Beta-cell function
Time frame: After 4 week treatment with active drug intervention versus placebo
Peripheral insulin extraction
Time frame: After 4 week treatment with active drug intervention versus placebo
Total insulin extraction
Time frame: After 4 week treatment with active drug intervention versus placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertugliflozin 15 mg in people with Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 7 inclusion and 23 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Renal oxygenation measured by BOLD-MRI (R2*) (time frame: After 4 week treatment with ertugliflozin 15mg QD versus placebo). 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 1 May 2023.