HemodialysisETERNITY-ITANCT06352957
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
An observational study of Hemodialysis, run by Istituto di Fisiologia Clinica CNR.
Trial summary
The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients
Who may be able to join
- Patient has provided informed consent;
- Patient is 18 years of age or older of both gender;
- Patients receiving maintenance HD three times per week (Kt/V >1.2);
- Parathyroid hormone concentrations >500 ng/l at screening, or if parathyroidectomy is planned or expected, Ca >8.3 mg/dl;
- Will be considered patients in the exposed group:
- Patients who have started Etelcalcetide within 1-month before the study enrolment;
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- Patients naïve to intravenous calcimimetics use;
- Patients who have suspended oral calcimimetics from at least 1-month;
- Patients who are not responder or not compliant to the treatment with calcitriol;
- In the unexposed group, patients on treatment with calcitriol or vitamin D analogs and who are age (± 2 years) and sex comparable (matching) to those in the exposed group will be considered;
- Native vitamin D can be used in both groups and should be administered to target a 25(OH)D level > 30 ng/ml;
- Dialysate calcium concentration must be stable for at least 4 weeks prior to screening laboratory assessments;
- Patient must have severe HPT as defined by two laboratory screening pre-dialysis serum PTH values > 500 pg/ml, measured on two consecutive lab checks prior to entering the study. PTH levels should be standardized according to the following table (Souberbielle et al. Kidney Int 2010);
- Total alkaline phosphatase greater than the normal range, or even within the normal range but if greater than the tertile of the reference range for the assay;
- Patients will be eligible only if they will show at least a moderate Aorta VCs and/or Iliac arteries VCs and at least a mild VF.
Who cannot join
- Previous treatment with oral calcimimetics (cinacalcet) must have been suspended for at least 30 days. Recent start of calcimimetics (Etelcalcetide) is acceptable, but patients are excluded if treatment lasts for more than 1 month;
- Patients has received a bisphosphonate, denosumab or teriparatide during the 12 months prior to screening;
- The patient underwent parathyroidectomy in the 6 months before the start of the study or if scheduled soon;
- Scheduled kidney transplant during the study period or anticipated living donor evaluation within three months of recruitment;
- Patient has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator;
- Metabolic bone diseases not related to the kidney (i.e., Pagets, Osteogenesis Imprefecta);
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- Severe untreated hyperthyroidism;
- Malignancy within the last 3 years (except non-melanoma skin cancers or cervical carcinoma in situ);
- Patient is pregnant or nursing;
- Patients with Long QT Syndrome;
- Patient likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the patient and Investigator's knowledge.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.
The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months.
Read the detailed description
Vascular calcifications (VCs) are frequent complications of chronic kidney disease (CKD), and mineral disorders are associated with aortic calcifications and increased risk of bone fractures. The complex pathogenesis of VCs involves various factors such as calcium overload, phosphate imbalance, and secondary hyperparathyroidism. Key inhibitors, such as vitamin K-dependent proteins (VKDPs) like matrix Gla protein (MGP) play pivotal roles in VCs development. Traditional treatments to reduce VC focus on lowering PTH, calcium and phosphorus levels and etelcalcetide revealed as a promising therapy to this scope. Accordingly, the VItamin K Italian study (VIKI) reported that calcimimetics treated hemodialysis patients had higher levels of total BGP and MGP versus those untreated, suggesting a protective effect of this drugs class. These findings point out the multifactorial nature of VC in CKD and suggest new treatment strategies and targeted pathways for improving outcomes. The ETERNITY-ITA study will investigate the real world effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP thus contributing to bone and vascular health in hemodialysis patients. ETERNITY-ITA is a multi-center comparative effectiveness, observational, longitudinal study. The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months.
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Matrix Gla protein, Osteocalcin or Bone GLA Protein (BGP), Vascular calcification, Vitamin K, Etecalcetide, Bone Fractures
- Medical subject headings
- Vascular Calcification, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Etecalcetide Group | Drug: Etelcalcetide Administered intravenously at the end of each dialysis session. Dosing ranges from 2.5 mg to 15 mg set by the patient's physician. Other Name: Parsabiv | |
| Standard of Care | Drug: Vitamin D or Vitamin D analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of VKDP
The primary endpoint is the comparison of the levels of active forms of VKDP between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues (MGP and BGP).
Measured: Baseline and after 3, 9, and 18 months of treatment
Secondary outcomes (41)
Calcium
Concentration of calcium (mg/dL)
Measured: Baseline, 3, 9 and 18-months
Phosphate
Concentration of phosphate (mg/dL)
Measured: Baseline, 3, 9 and 18-months
Magnesium
Concentration of magnesium (mg/dL)
Measured: Baseline, 3, 9 and 18-months
ALP
Concentration of ALP (U/L)
Measured: Baseline, 3, 9 and 18-months
PTH
Concentration of PTH (pg/ml)
Measured: Baseline, 3, 9 and 18-months
25(OH)D
Concentration of 25(OH)D (ng/mL)
Measured: Baseline, 3, 9 and 18-months
P1NP
Concentration of Procollagen I Intact N-Terminal or P1NP (ug/L )
Measured: Baseline, 3, 9 and 18-months
CTX
Concentration of C-terminal telopeptide or CTX (pg/mL)
Measured: Baseline, 3, 9 and 18-months
TRAP 5b
Concentration of Tartrate-resistant acid phosphatase 5b or TRAP 5bC-Terminal to Intact (U/L)
Measured: Baseline, 3, 9 and 18-months
BSAP
Concentration of Bone-specific alkaline phosphatase or BSAP (mcg/L)
Measured: Baseline, 3, 9 and 18-months
cFGF23
Concentration of Fibroblast Growth Factor 23 or cFGF23 (pmol/L) and iFGF23 (pg/mL)
Measured: Baseline, 3, 9 and 18-months
Klotho
Concentration of Klotho (pg/mL) and soluble α-Klotho (pg/mL)
Measured: Baseline, 3, 9 and 18-months
Sclerostin
Concentration of Sclerostin and Bioactive Sclerostin (pmol/L)
Measured: Baseline, 3, 9 and 18-months
DKK1
Concentration of DKK1 (pmol/L)
Measured: Baseline, 3, 9 and 18-months
Fetuin A
Concentration of Fetuin A (ng/mL)
Measured: Baseline, 3, 9 and 18-months
Zinc
Concentration of Zinc (μmol/L)
Measured: Baseline, 3, 9 and 18-months
Irisin
Concentration of Irisin
Measured: Baseline, 3, 9 and 18-months
Serum Calcification Propensity T50 test
Serum Calcification Propensity T50 test (minutes)
Measured: Baseline, 3, 9 and 18-months
Hemoglobin (Hb)
Concentration of Hemoglobin (g/dl)
Measured: Baseline, 3, 9 and 18-months
Hematocrit (Ht)
Concentration of Hematocrit (%)
Measured: Baseline, 3, 9 and 18-months
Plates (PLTS)
Concentration of plates (g/L)
Measured: Baseline, 3, 9 and 18-months
Reticulocytes
Concentration of reticulocytes (%)
Measured: Baseline, 3, 9 and 18-months
Iron
Concentration of iron (µg/dL)
Measured: Baseline, 3, 9 and 18-months
Ferritin
Concentration of ferritin (ng/ml )
Measured: Baseline, 3, 9 and 18-months
Transferrin
Concentration of transferrin (mg/dL)
Measured: Baseline, 3, 9 and 18-months
Transferrin Saturation
Transferrin saturation (%)
Measured: Baseline, 3, 9 and 18-months
Albumin
Concentration of Albumin (g/dl)
Measured: Baseline, 3, 9 and 18-months
KT/V
Level of KT/V
Measured: Baseline, 3, 9 and 18-months
Aluminium
Concentration of aluminium (mcg/L)
Measured: Baseline, 3, 9 and 18-months
C-reactive Protein (CRP)
Concentration of C-reactive Protein (mg/L)
Measured: Baseline, 3, 9 and 18-months
Cholesterol
Concentration of cholesterol (mg/dl)
Measured: Baseline, 3, 9 and 18-months
Triglycerides
Concentration of triglycerides (mg/dl)
Measured: Baseline, 3, 9 and 18-months
Cholesterol HDL
Concentration of Cholesterol HDL (mg/dl)
Measured: Baseline, 3, 9 and 18-months
Cholesterol LDL
Concentration of Cholesterol LDL (mg/dl)
Measured: Baseline, 3, 9 and 18-months
Vascular Calcification
Number of participants with vascular calcification (Aorta and Iliac arteries) by lateral Dorsal Lumbar spine x-Ray.
Measured: Baseline, 18-months
Vertebral Fractures
Changes from baseline prevalence Vertebral Fractures (VFs, quantitative vertebral morphometry using dedicated software) by lateral Dorsal Lumbar spine x-Ray
Measured: Baseline, 18-months
BMD: Bone Mineral Density
Changes from baseline Total Hip, Femoral neck Bone Mass Density (BMD) by Dual-energy X-ray absorptiometry (DEXA) including Trabecular Bone Score where it will be available (TBS).
Measured: Baseline, 18-months
Association between Verterbal Fractures and Vascular Calcificatiom
To evaluate the relationship of bone vascular biomarkers on clinical outcomes: VFs and VCs
Measured: Baseline, 18-months
Novel quantitative computer-assisted scoring method for vascular calcifications.
To compare a novel quantitative computer-assisted scoring method for vascular calcifications with a three-dimensional assessment from CT data
Measured: Baseline, 18-months
Effect of Etelcalcetide on cardiovascular events and all-cause mortality.
Effect of Etelcalcetide on the number of cardiovascular events and on the number of all-cause deaths.
Measured: Baseline, 18-months
Etelcalcetide Safety: Number of participants with treatment-related adverse events.
The outcome can identify potential adverse events, such as: Blood calcium decrease, Muscle spasms, Diarrhea, Nausea, Vomiting, Headache, Hypocalcaemia, Hypertension, Hypotension, Arteriovenous fistula site complication, Pain in extremity, Paresthesia, Back pain, Upper respiratory tract infection.
Measured: Baseline, 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto di Fisiologia Clinica CNR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352957
- Sponsor's protocol ID
- 23022022CERC
- Acronym
- ETERNITY-ITA
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
- ClinicalTrials.gov ID
- NCT06352957
- Acronym / sponsor ID
- ETERNITY-ITA / 23022022CERC
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Matrix Gla protein, Osteocalcin or Bone GLA Protein (BGP), Vascular calcification, Vitamin K, Etecalcetide, Bone Fractures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Istituto di Fisiologia Clinica CNRUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.
The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months.
Detailed description
Vascular calcifications (VCs) are frequent complications of chronic kidney disease (CKD), and mineral disorders are associated with aortic calcifications and increased risk of bone fractures. The complex pathogenesis of VCs involves various factors such as calcium overload, phosphate imbalance, and secondary hyperparathyroidism. Key inhibitors, such as vitamin K-dependent proteins (VKDPs) like matrix Gla protein (MGP) play pivotal roles in VCs development. Traditional treatments to reduce VC focus on lowering PTH, calcium and phosphorus levels and etelcalcetide revealed as a promising therapy to this scope. Accordingly, the VItamin K Italian study (VIKI) reported that calcimimetics treated hemodialysis patients had higher levels of total BGP and MGP versus those untreated, suggesting a protective effect of this drugs class. These findings point out the multifactorial nature of VC in CKD and suggest new treatment strategies and targeted pathways for improving outcomes. The ETERNITY-ITA study will investigate the real world effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP thus contributing to bone and vascular health in hemodialysis patients. ETERNITY-ITA is a multi-center comparative effectiveness, observational, longitudinal study. The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etecalcetide Group | – | –Drug: Etelcalcetide Administered intravenously at the end of each dialysis session. Dosing ranges from 2.5 mg to 15 mg set by the patient's physician. Other Name: Parsabiv |
| Standard of Care | – | –Drug: Vitamin D or Vitamin D analogs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients
Key inclusion criteria (15 listed)
- Patient has provided informed consent;
- Patient is 18 years of age or older of both gender;
- Patients receiving maintenance HD three times per week (Kt/V >1.2);
- Parathyroid hormone concentrations >500 ng/l at screening, or if parathyroidectomy is planned or expected, Ca >8.3 mg/dl;
- Will be considered patients in the exposed group:
Key exclusion criteria (11 listed)
- Previous treatment with oral calcimimetics (cinacalcet) must have been suspended for at least 30 days. Recent start of calcimimetics (Etelcalcetide) is acceptable, but patients are excluded if treatment lasts for more than 1 month;
- Patients has received a bisphosphonate, denosumab or teriparatide during the 12 months prior to screening;
- The patient underwent parathyroidectomy in the 6 months before the start of the study or if scheduled soon;
- Scheduled kidney transplant during the study period or anticipated living donor evaluation within three months of recruitment;
- Patient has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of VKDP
Time frame: Baseline and after 3, 9, and 18 months of treatment
The primary endpoint is the comparison of the levels of active forms of VKDP between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues (MGP and BGP).
41 secondary outcomes
Calcium
Time frame: Baseline, 3, 9 and 18-months
Phosphate
Time frame: Baseline, 3, 9 and 18-months
Magnesium
Time frame: Baseline, 3, 9 and 18-months
ALP
Time frame: Baseline, 3, 9 and 18-months
PTH
Time frame: Baseline, 3, 9 and 18-months
25(OH)D
Time frame: Baseline, 3, 9 and 18-months
P1NP
Time frame: Baseline, 3, 9 and 18-months
CTX
Time frame: Baseline, 3, 9 and 18-months
TRAP 5b
Time frame: Baseline, 3, 9 and 18-months
BSAP
Time frame: Baseline, 3, 9 and 18-months
cFGF23
Time frame: Baseline, 3, 9 and 18-months
Klotho
Time frame: Baseline, 3, 9 and 18-months
Sclerostin
Time frame: Baseline, 3, 9 and 18-months
DKK1
Time frame: Baseline, 3, 9 and 18-months
Fetuin A
Time frame: Baseline, 3, 9 and 18-months
Zinc
Time frame: Baseline, 3, 9 and 18-months
Irisin
Time frame: Baseline, 3, 9 and 18-months
Serum Calcification Propensity T50 test
Time frame: Baseline, 3, 9 and 18-months
Hemoglobin (Hb)
Time frame: Baseline, 3, 9 and 18-months
Hematocrit (Ht)
Time frame: Baseline, 3, 9 and 18-months
Plates (PLTS)
Time frame: Baseline, 3, 9 and 18-months
Reticulocytes
Time frame: Baseline, 3, 9 and 18-months
Iron
Time frame: Baseline, 3, 9 and 18-months
Ferritin
Time frame: Baseline, 3, 9 and 18-months
Transferrin
Time frame: Baseline, 3, 9 and 18-months
Transferrin Saturation
Time frame: Baseline, 3, 9 and 18-months
Albumin
Time frame: Baseline, 3, 9 and 18-months
KT/V
Time frame: Baseline, 3, 9 and 18-months
Aluminium
Time frame: Baseline, 3, 9 and 18-months
C-reactive Protein (CRP)
Time frame: Baseline, 3, 9 and 18-months
Cholesterol
Time frame: Baseline, 3, 9 and 18-months
Triglycerides
Time frame: Baseline, 3, 9 and 18-months
Cholesterol HDL
Time frame: Baseline, 3, 9 and 18-months
Cholesterol LDL
Time frame: Baseline, 3, 9 and 18-months
Vascular Calcification
Time frame: Baseline, 18-months
Vertebral Fractures
Time frame: Baseline, 18-months
BMD: Bone Mineral Density
Time frame: Baseline, 18-months
Association between Verterbal Fractures and Vascular Calcificatiom
Time frame: Baseline, 18-months
Novel quantitative computer-assisted scoring method for vascular calcifications.
Time frame: Baseline, 18-months
Effect of Etelcalcetide on cardiovascular events and all-cause mortality.
Time frame: Baseline, 18-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Istituto di Fisiologia Clinica CNR.
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 15 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: opening soon, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Maria Fusaro, MD (0965393253, dante.lucia11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of VKDP (time frame: Baseline and after 3, 9, and 18 months of treatment). 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 8 Apr 2024.