End Stage Renal DiseaseNCT04786535
Efficacy of Uremic Toxins Clearance With Expanded Hemodialysis
A study testing Expanded Hemodialysis, High-flux Conventional Hemodialysis and Hemodiafiltration in people with End Stage Renal Disease, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
The aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), or HDF (hemodiafiltration). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Expanded Hemodialysis, High-flux Conventional Hemodialysis and Hemodiafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteMexico
- Study dates
- 10 May 2021to 1 Jan 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years
- Anuric patients (residual urinary volume ≤ 100 mL/24 h)
- Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each)
- Without modification of their prescription in the last three months
- Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both
- Letter of acceptance to enter the protocol and a signed informed consent.
Who cannot join
- Under 18 years
- Active intake or intake in the last six months of immunosuppressants or systemic steroids
- Active autoimmune disease
- Evidence of active systemic infectious event at the time of inclusion or two weeks prior
- Diagnosis of neoplasia or active oncological disease
- Hypoalbuminemia (< 3.2 g/dL)
- Pregnancy or lactation
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
Olynka Vega-Vega, MD, +52 1 55 4803 9428, olynkavega@hotmail.com
Ricardo Correa-Rotter, MD, +52 1 55 7959 7066, correarotter@gmail.com
About this study
Official title: Crossover Study of Three Groups Comparing the Efficacy of Uremic Toxins Clearance of Expanded Hemodialysis With Two Hemodialysis Membranes for Conventional Hemodialysis and Hemodiafiltration
The aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), or HDF (hemodiafiltration).
And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
Read the detailed description
A controlled, randomized, crossover clinical trial is planned to compare the magnitude of the B2-microglobulin reduction rate in three different extracorporeal therapies (ETs): HDc, HDx, and HDF.
The selection of study participants will be consecutive and for convenience
This study will be divided into six periods: three treatment periods (one for each therapy to be compared) and three of "washout" periods (interspersed between the treatment periods). The treatment periods will last four weeks (12 ET sessions, three per week) and will be preceded by a one-week washout period (three ET sessions)
After inclusion in the protocol, participants will be randomly assigned (with the help of a table of random numbers) to one of three ETs to be evaluated (HDc, HDx, or HDF). Afterwards, the first washout period will begin with high-flow conventional hemodialysis (HDc). At the end of the first washout period, the ET randomly assigned to one of three ETs to be evaluated (HDc, HDx, or HDF), following the sequence: Washout 1 -> Period 1 (HDC, HDx, or HDF) -> Washout 2 -> Period 2, etc.
For each period of ET, there will be two sampling times: baseline and final
Blood samples will be obtained through the arterial port of the extracorporeal circuit, at the beginning and at the end of the ET session. The "slow flow" method will be used (UF: 0 mL/min, Qd: 0 mL/min, and Qb: 100 mL/min, for 30 seconds, before extracting the sample from the arterial port) (24). Blood samples will be collected in dry tubes (without anticoagulant) and centrifuged for 10 minutes at 3,000 RPM. The supernatant will be divided into three aliquots and stored at -70°C for further processing.
To calculate sample size, the formula for a noninferiority study was used (Pharmaceutical statistics. 2016;15(1):80-9), which is detailed below:
n= ((r+1) (Z_(1-β)+Z_(1-α) )^2 σ^2)/(r((μ_A-μ_B )-d_NI )^2 )
The terms above, are substituted with values obtained from the publication of Kirsch et al. (Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172) as follows:
Objective: Non-inferiority (Ho µA - µB ≤ -dNI vs. µA - µB > -dNI) Outcome: B2-microglobulin reduction rate. r: allocation ratio by group:1 beta: type II error (90% power):1.2816 alpha: type I error (level of significance 5%):1.960 (variance in the population):1.33 µA - µB (magnitude of the observed effect):80.6 - 78.5 = 2.1 dNI (non-inferiority limit): 3.5
n= ((1+1) (1.2816+1.960)^2 〖(1.33)〗^2)/(1((2.1)-3.5)^2 )= 19, the investigators estimate a 20 % loss in the follow-up , then investigators consider a sample size of n = 23 patients
The nominal variables will be presented in frequencies and proportions. Continuous numerical variables will be analyzed using the Kolmogorov-Smirnov "Z" test to determine their distribution. The results will be shown as the means ± standard deviation in case of normal distribution and as a median with minimum and maximum limits for variables with non-normal distribution.
The total serum concentration of the biochemical variables in general as well as the uremic toxins will be analyzed. Additionally, the reduction rate and purification of the uremic toxins will be analyzed.
The analyses of the inter- and intra-group differences will be performed using the one-way multiple comparisons (ANOVA) method. Post hoc analysis using the Bonferroni method will be used in cases where the groups present a normal distribution; otherwise, the Kruskal-Wallis method will be used. A result with a p < 0.05 will be considered significant
- Conditions
- End Stage Renal Disease
- Being tested
- Expanded Hemodialysis, High-flux Conventional Hemodialysis, Hemodiafiltration
- Keywords
- Uremic Toxins, Hemodiafiltration, Expanded Hemodialysis, High-Flux Conventional Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded HemodialysisProcedure or surgery
- Single-use Theranova 400 Dialyzer
- Blood flow (Qb) minimum of 300 mL/min
- Dialysis flow (Qd) 500 mL/min
- Minimum therapy time of 4 hours
- Ultrafiltration necessary to achieve dry weight
High-flux Conventional HemodialysisProcedure or surgery
- Single-use high-flux hemodialyzer
- Blood flow (Qb) minimum of 300 mL/min
- Dialysis flow (Qd) 500 mL/min
- Minimum therapy time of 4 hours
- Ultrafiltration necessary to achieve dry weight
HemodiafiltrationProcedure or surgery
- Single-use high-flux hemodialyzer
- Post-dilution mode
- Minimum convective volume of 23 L
- Blood flow (Qb) minimum of 300 mL/min
- Dialysis flow (Qd) 700 mL/min
- Minimum therapy time of 4 hours
- Ultrafiltration necessary to achieve dry weight
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration | Active comparator | Not described Receives: Procedure: Hemodiafiltration |
| Expanded hemodialysis | Experimental | Not described Receives: Procedure: Expanded Hemodialysis |
| Conventional high-flux hemodialysis | Experimental | Not described Receives: Procedure: High-flux Conventional Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
B2-microglobulin reduction rate
B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
Measured: At final of each period of ET (4 weeks)
Secondary outcomes (5)
Urea reduction rate
Urea reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
Measured: At final of each period of ET (4 weeks)
Phosphorus reduction rate
Phosphorus reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
Measured: At final of each period of ET (4 weeks)
Interleukin 6 reduction rate
Interleukin 6 reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
Measured: At final of each period of ET (4 weeks)
P-cresol reduction rate
P-cresol reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
Measured: At final of each period of ET (4 weeks)
Tumor necrosis factor-a reduction rate
Tumor necrosis factor-a reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
Measured: At final of each period of ET (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start10 May 2021
- Primary completion6 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter México
- Responsible party
- Sponsor
- Investigators
- Ricardo Correa-Rotter, MD, Principal investigator, Head Departament of Nephrology and Mineral Metabolism,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786535
- Sponsor's protocol ID
- REF.2937
- Status last verified
- Sep 2021
- First submitted
- 3 Mar 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belmouaz M, Diolez J, Bauwens M, Duthe F, Ecotiere L, Desport E, Bridoux F. Comparison of hemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules . Clin Nephrol. 2018 Jan;89 (2018)(1):50-56. doi: 10.5414/CN109133 .
PubMed 28853700Ronco C. The Rise of Expanded Hemodialysis. Blood Purif. 2017;44(2):I-VIII. doi: 10.1159/000476012. Epub 2017 May 10.
PubMed 28486230Ronco C, Marchionna N, Brendolan A, Neri M, Lorenzin A, Martinez Rueda AJ. Expanded haemodialysis: from operational mechanism to clinical results. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii41-iii47. doi: 10.1093/ndt/gfy202.
PubMed 30281134Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
PubMed 28085888Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
PubMed 27587605
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Study of Three Groups Comparing the Efficacy of Uremic Toxins Clearance of Expanded Hemodialysis With Two Hemodialysis Membranes for Conventional Hemodialysis and Hemodiafiltration
- ClinicalTrials.gov ID
- NCT04786535
- Acronym / sponsor ID
- REF.2937
- Conditions
- End Stage Renal Disease
- Keywords
- Uremic Toxins, Hemodiafiltration, Expanded Hemodialysis, High-Flux Conventional Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Baxter México
- Study start
- 10 May 2021 (actual)
- Primary completion
- 6 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 8 Mar 2021 (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 aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), or HDF (hemodiafiltration).
And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
Detailed description
A controlled, randomized, crossover clinical trial is planned to compare the magnitude of the B2-microglobulin reduction rate in three different extracorporeal therapies (ETs): HDc, HDx, and HDF.
The selection of study participants will be consecutive and for convenience
This study will be divided into six periods: three treatment periods (one for each therapy to be compared) and three of "washout" periods (interspersed between the treatment periods). The treatment periods will last four weeks (12 ET sessions, three per week) and will be preceded by a one-week washout period (three ET sessions)
After inclusion in the protocol, participants will be randomly assigned (with the help of a table of random numbers) to one of three ETs to be evaluated (HDc, HDx, or HDF). Afterwards, the first washout period will begin with high-flow conventional hemodialysis (HDc). At the end of the first washout period, the ET randomly assigned to one of three ETs to be evaluated (HDc, HDx, or HDF), following the sequence: Washout 1 -> Period 1 (HDC, HDx, or HDF) -> Washout 2 -> Period 2, etc.
For each period of ET, there will be two sampling times: baseline and final
Blood samples will be obtained through the arterial port of the extracorporeal circuit, at the beginning and at the end of the ET session. The "slow flow" method will be used (UF: 0 mL/min, Qd: 0 mL/min, and Qb: 100 mL/min, for 30 seconds, before extracting the sample from the arterial port) (24). Blood samples will be collected in dry tubes (without anticoagulant) and centrifuged for 10 minutes at 3,000 RPM. The supernatant will be divided into three aliquots and stored at -70°C for further processing.
To calculate sample size, the formula for a noninferiority study was used (Pharmaceutical statistics. 2016;15(1):80-9), which is detailed below:
n= ((r+1) (Z_(1-β)+Z_(1-α) )^2 σ^2)/(r((μ_A-μ_B )-d_NI )^2 )
The terms above, are substituted with values obtained from the publication of Kirsch et al. (Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172) as follows:
Objective: Non-inferiority (Ho µA - µB ≤ -dNI vs. µA - µB > -dNI) Outcome: B2-microglobulin reduction rate. r: allocation ratio by group:1 beta: type II error (90% power):1.2816 alpha: type I error (level of significance 5%):1.960 (variance in the population):1.33 µA - µB (magnitude of the observed effect):80.6 - 78.5 = 2.1 dNI (non-inferiority limit): 3.5
n= ((1+1) (1.2816+1.960)^2 〖(1.33)〗^2)/(1((2.1)-3.5)^2 )= 19, the investigators estimate a 20 % loss in the follow-up , then investigators consider a sample size of n = 23 patients
The nominal variables will be presented in frequencies and proportions. Continuous numerical variables will be analyzed using the Kolmogorov-Smirnov "Z" test to determine their distribution. The results will be shown as the means ± standard deviation in case of normal distribution and as a median with minimum and maximum limits for variables with non-normal distribution.
The total serum concentration of the biochemical variables in general as well as the uremic toxins will be analyzed. Additionally, the reduction rate and purification of the uremic toxins will be analyzed.
The analyses of the inter- and intra-group differences will be performed using the one-way multiple comparisons (ANOVA) method. Post hoc analysis using the Bonferroni method will be used in cases where the groups present a normal distribution; otherwise, the Kruskal-Wallis method will be used. A result with a p < 0.05 will be considered significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemodiafiltration | Active comparator | Procedure: Hemodiafiltration |
| Expanded hemodialysis | Experimental | Procedure: Expanded Hemodialysis |
| Conventional high-flux hemodialysis | Experimental | Procedure: High-flux Conventional Hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years
- Anuric patients (residual urinary volume ≤ 100 mL/24 h)
- Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each)
- Without modification of their prescription in the last three months
- Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both
Key exclusion criteria (8 listed)
- Under 18 years
- Active intake or intake in the last six months of immunosuppressants or systemic steroids
- Active autoimmune disease
- Evidence of active systemic infectious event at the time of inclusion or two weeks prior
- Diagnosis of neoplasia or active oncological disease
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 |
|---|---|---|
| Expanded Hemodialysis* Single-use Theranova 400 Dialyzer * Blood flow (Qb) minimum of 300 mL/min * Dialysis flow (Qd) 500 mL/min * Minimum therapy time of 4 hours * Ultrafiltration necessary to achieve dry weight | Procedure or surgery | Expanded hemodialysis |
| High-flux Conventional Hemodialysis* Single-use high-flux hemodialyzer * Blood flow (Qb) minimum of 300 mL/min * Dialysis flow (Qd) 500 mL/min * Minimum therapy time of 4 hours * Ultrafiltration necessary to achieve dry weight | Procedure or surgery | Conventional high-flux hemodialysis |
| Hemodiafiltration* Single-use high-flux hemodialyzer * Post-dilution mode * Minimum convective volume of 23 L * Blood flow (Qb) minimum of 300 mL/min * Dialysis flow (Qd) 700 mL/min * Minimum therapy time of 4 hours * Ultrafiltration necessary to achieve dry weight | Procedure or surgery | Hemodiafiltration |
Primary outcome
B2-microglobulin reduction rate
Time frame: At final of each period of ET (4 weeks)
B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
5 secondary outcomes
Urea reduction rate
Time frame: At final of each period of ET (4 weeks)
Phosphorus reduction rate
Time frame: At final of each period of ET (4 weeks)
Interleukin 6 reduction rate
Time frame: At final of each period of ET (4 weeks)
P-cresol reduction rate
Time frame: At final of each period of ET (4 weeks)
Tumor necrosis factor-a reduction rate
Time frame: At final of each period of ET (4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 28853700Belmouaz M, Diolez J, Bauwens M, Duthe F, Ecotiere L, Desport E, Bridoux F. Comparison of hemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules . Clin Nephrol. 2018 Jan;89 (2018)(1):50-56. doi: 10.5414/CN109133 .
- Background: PubMed 28486230Ronco C. The Rise of Expanded Hemodialysis. Blood Purif. 2017;44(2):I-VIII. doi: 10.1159/000476012. Epub 2017 May 10.
- Background: PubMed 30281134Ronco C, Marchionna N, Brendolan A, Neri M, Lorenzin A, Martinez Rueda AJ. Expanded haemodialysis: from operational mechanism to clinical results. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii41-iii47. doi: 10.1093/ndt/gfy202.
- Background: PubMed 28085888Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
- Background: PubMed 27587605Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Correa-Rotter, MD principal investigator
Head Departament of Nephrology and Mineral Metabolism,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Hemodialysis, High-flux Conventional Hemodialysis and Hemodiafiltration in people with End Stage Renal Disease, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. 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 Mexico. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olynka Vega-Vega, MD (+52 1 55 4803 9428, olynkavega@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B2-microglobulin reduction rate (time frame: At final of each period of ET (4 weeks)). 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 NCT04786535, which also lists 5 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 17 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.