Chronic Kidney DiseasesPhase 3NCT03551119
Physical Activity in Renal Disease (PAIRED): The Effect on Hypertension
A Phase 3 study testing Exercise in people with Chronic Kidney Diseases, run by University of Alberta at 3 sites in Canada.
Trial summary
Background and importance: Hypertension is highly prevalent among Canadians with non-dialysis dependent chronic kidney disease (CKD). It is a modifiable risk factor for both cardiovascular (CV) events and CKD progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesCanada
- Study dates
- 21 Nov 2018to 20 Aug 2020
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resting SBP >120 mmHg systolic on screening BP clinic measurements (with an electronic sphygmomanometer, mean of three readings after first reading is discarded) and at least one previous SBP measurement above 120 mmHg on a separate occasion within the past six months (home or clinic measurement).
- Stable on blood pressure medications for the past eight weeks
- eGFR 15-44 ml/min per 1.73m2 eGFR between 15-44 ml/min per 1.73m2 within the last three months and one additional value in this rage in the last 12 months.
- Independent ambulation with or without an assistive device for at least three consecutive minutes
- Cognition and English language sufficient enough to understand written information, provide consent, and comply with the testing and interventions
- Approval of the attending nephrologist
- No significant exercise-induced arrhythmia or new ischemia on submaximal incremental exercise testing (final screening step)
Who cannot join
- Resting SBP >160 mmHg or DBP > 110 mmHg on screening BP clinic measurement (Note: the individual may be re-screened 8 weeks after medication adjustment)
- Arm circumference greater than 54 centimeters (size limit of large ABPM cuff)
- Recent (<6 weeks) or planned (<6 months) major cardiovascular events or procedures
- Any known contraindication to exercise (American College of Sports Medicine Guidelines)
- Acute myocardial infarction (3-5 days) or unstable angina; Uncontrolled symptomatic arrhythmias; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Acute pulmonary embolism or deep vein thrombosis; Suspected dissecting aneurysm; Uncontrolled asthma; Uncontrolled pulmonary edema; Room air desaturation to <85%; Acute non-cardiopulmonary disorder that may affect exercise performance (infection, orthopedic problem); Mental impairment leading to inability to cooperate; Uncontrolled hypertension (as above)
- Pregnant or planning to become pregnant
Show all 12Show fewer
- Transplant
- Life expectancy or predicted time to renal replacement therapy <9 months (attending physician judgment)
- Planned move or hospital admission within the next 9 months
- Currently enrolled in an interventional clinical trial; currently enrolled in a structured exercise program or performing regular exercise training > 2 day/week in the last 3 months
- Taking other medications known to affect blood pressure (prednisone cyclosporine) and expected adjustment in the next 9 months
- Significant barrier to participation in a home exercise program or an insurmountable barrier to attend in-center training sessions.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital, outpatient dialysis unit
Edmonton, Alberta, T6G 2P4
Grey Nuns Hospital
Edmonton, Alberta, T6L5X8
About this study
Official title: Physical Activity in Renal Disease (PAIRED): A Randomized Controlled Trial of the Effect on Hypertension
Background and importance: Hypertension is highly prevalent among Canadians with non-dialysis dependent chronic kidney disease (CKD). It is a modifiable risk factor for both cardiovascular (CV) events and CKD progression. Exercise is an effective strategy for blood pressure (BP) reduction in the general population but in people with CKD, hypertension is mediated by different causes (i.e. vascular stiffness, volume expansion) and it is unclear whether exercise will reduce BP in this population. Consequently, exercise resources are not offered in the routine multidisciplinary care of people with CKD and the prevalence of sedentary behaviour remains double that of the general population. The role of exercise in CKD management is also an important question for patients. From CIHR-supported workshops with patients, the role of lifestyle, such as exercise in CKD was a top research priority.
Research aims: i.To determine the effect of exercise on mean ambulatory systolic blood pressure (SBP) in people with CKD compared to usual care. The investigators hypothesize that exercise training will significantly reduce BP compared to control. ii.To inform the design of a larger, multi-center trial evaluating the effect of exercise on the risk of CKD progression.
Read more
Methods: A 160 participant, single center randomized trial of adults from Alberta Kidney Care North CKD clinics, Edmonton, Albert, Canada. Participants with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min per 1.73m2 and SBP >130 mmHg will be randomized, stratified by eGFR (<30 versus ≥ 30) to an exercise intervention or usual care. The main outcome is the difference in 24-hour ambulatory SBP after eight weeks of exercise training between groups. Secondary outcomes include: BPs at eight and 24 weeks, dose of anti-hypertensives, aortic stiffness, CV-risk markers, CV fitness, 7-day accelerometry, quality of life, safety, and in an exploratory analysis, eGFR and proteinuria. The intervention is thrice weekly moderate intensity aerobic exercise supplemented with isometric resistance exercise, targeting 150 minutes per week and delivered over 24-weeks. Phase 1: one supervised weekly sessions and home-based sessions (eight weeks). Phase 2: home-based sessions (16 weeks). To detect a clinically important BP reduction of 5 mmHg between groups requires 128 patients (two sample t-test, alpha 0.05, beta 0.2, common standard deviation of 10 mmHg). Assuming 20% dropout requires 160 patients. For the primary outcome, the investigators will use a mixed linear regression model in which BP is regressed on group, baseline SBP and eGFR, and time point.
Expected outcomes: The findings from this study will address a significant knowledge gap in hypertension management in CKD, inform care-delivery and the design of a larger study on CKD progression. This proposal aligns with priorities for both patients and decision makers: to identify the role of exercise in CKD management and to reshape the delivery of renal care so that it is more consistent with patient values and preferences.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Exercise, Enhanced usual care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
See previous description
Enhanced usual careOther
See previous description
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Personnel experienced in training people with chronic conditions (exercise specialist) will supervise the exercise training. At each in-center session in phase 1, the patient's exercise will be monitored to assess whether they are achieving target levels. Training intensities will be prescribed based on the most recent exercise test.
Phase 1: an eight-week program of once weekly-supervised facility-based exercise sessions and twice weekly home-based sessions.
Phase 2: a 16-week home-based exercise program overseen by an exercise specialist. During this phase, participants will be progressed through their home-based exercise program from Phase 1 on an individual basis.
i. Frequency. A minimum of three exercise sessions per week. ii. Intensity. A moderate intensity (40-60% heart rate reserve) based on exercise testing.
iii. Time. 150 minutes of exercise per week. iv. Type. We will prescribe aerobic exercise supplemented with isometric resistance exercises. Receives: Behavioral: Exercise |
| Enhanced usual care | Other | Participants in the control group will perform accelerometry. This is enhanced usual care because physical activity measurement is not routinely performed in CKD clinics. Control arm participants will only receive their accelerometry data after they have completed the study. Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour ambulatory SBP
mean 24-hour ambulatory systolic blood pressure
Measured: 8 weeks
Secondary outcomes (30)
antihypertensive use
Using the assigned DDD (WHO) for that drug
Measured: 8 and 24 weeks
KDQOL-36
Kidney Disease and Quality of Life instrument - this is a short form that includes the SF-12 plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF
Measured: 8 and 24 weeks
IPAQ-SF
International Physical Activity Questionnaire - Short Form
Measured: 8 and 24 weeks
SEE scale
Self Efficacy for Exercise questionnaire - the total score ranges from 0 to 90. High scores indicate higher self-efficacy in exercise. There are 9 questions; responses vary from 0 to 10. The mean score on each question is 5.5.
Measured: 8 and 24 weeks
EQ-5D
European Quality of Life (EuroQOL) health questionnaire with 5 dimensions
Measured: 8 and 24 weeks
pulse wave velocity
measurement of aortic stiffness (femoral carotid, radial carotid)
Measured: 8 and 24 weeks
body mass index
calculated as weight in kilograms divided by height in meters squared
Measured: 8 and 24 weeks
Fat mass
Body composition using bioimpedance spectroscopy
Measured: 8 and 24 weeks
clinic blood pressure
with a oscillometric sphygmomanometer
Measured: 8 and 24 weeks
Oxygen uptake (VO2 peak)
Cardiopulmonary exercise testing
Measured: 8 and 24 weeks
estimated glomerular filtration rate
Measured: 8 and 24 weeks
c-reactive protein
Measured: 8 and 24 weeks
total cholesterol
Measured: 8 and 24 weeks
LDL
Measured: 8 and 24 weeks
HDL
Measured: 8 and 24 weeks
triglycerides
Measured: 8 and 24 weeks
HgA1C
glycated hemoglobin
Measured: 24 weeks
spot urinary sodium
measured on a non-exercise day
Measured: 8 and 24 weeks
spot urinary protein
measured on a non-exercise day
Measured: 8 and 24 weeks
7-day accelerometry
number of steps
Measured: 8 and 24 weeks
7-day accelerometry
sedentary time
Measured: 8 and 24 weeks
7-day accelerometry
time in light activity
Measured: 8 and 24 weeks
7-day accelerometry
time in moderate activity
Measured: 8 and 24 weeks
7-day accelerometry
time in vigorous activity
Measured: 8 and 24 weeks
7-day accelerometry
time in very vigorous activity
Measured: 8 and 24 weeks
7-day accelerometry
METS
Measured: 8 and 24 weeks
7-day accelerometry
sedentary bouts
Measured: 8 and 24 weeks
24-hour ABPM
daytime, night time systolic and diastolic BP
Measured: 8 and 24 weeks
Adherence
70% of in centre sessions attended and 70% of home sessions performed prescribed (accelerometry and log book)
Measured: 8 and 24 weeks
Body cell mass
Body composition using bioimpedance spectroscopy
Measured: 8 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start21 Nov 2018
- Primary completion13 Aug 2020
- Study completion20 Aug 2020
Why it stopped: Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this parallel arm control trial, participants recruited from outpatient CKD clinics in Alberta Kidney Care North, Edmonton, Alberta, Canada will be randomized (1:1) to enhanced usual care (measurement of physical activity levels) or an exercise intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Stephanie Thompson, University of Alberta
- Investigators
- Stephanie Thompson, MD PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551119
- Sponsor's protocol ID
- Pro00078564
- Status last verified
- Apr 2021
- First submitted
- 12 May 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thompson S, Wiebe N, Gyenes G, Davies R, Radhakrishnan J, Graham M. Physical Activity In Renal Disease (PAIRED) and the effect on hypertension: study protocol for a randomized controlled trial. Trials. 2019 Feb 8;20(1):109. doi: 10.1186/s13063-019-3235-5.
PubMed 30736832
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Renal Disease (PAIRED): A Randomized Controlled Trial of the Effect on Hypertension
- ClinicalTrials.gov ID
- NCT03551119
- Acronym / sponsor ID
- Pro00078564
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 pandemic
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 11 Jun 2018 (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.
Background and importance: Hypertension is highly prevalent among Canadians with non-dialysis dependent chronic kidney disease (CKD). It is a modifiable risk factor for both cardiovascular (CV) events and CKD progression. Exercise is an effective strategy for blood pressure (BP) reduction in the general population but in people with CKD, hypertension is mediated by different causes (i.e. vascular stiffness, volume expansion) and it is unclear whether exercise will reduce BP in this population. Consequently, exercise resources are not offered in the routine multidisciplinary care of people with CKD and the prevalence of sedentary behaviour remains double that of the general population. The role of exercise in CKD management is also an important question for patients. From CIHR-supported workshops with patients, the role of lifestyle, such as exercise in CKD was a top research priority.
Research aims: i.To determine the effect of exercise on mean ambulatory systolic blood pressure (SBP) in people with CKD compared to usual care. The investigators hypothesize that exercise training will significantly reduce BP compared to control. ii.To inform the design of a larger, multi-center trial evaluating the effect of exercise on the risk of CKD progression.
Methods: A 160 participant, single center randomized trial of adults from Alberta Kidney Care North CKD clinics, Edmonton, Albert, Canada. Participants with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min per 1.73m2 and SBP >130 mmHg will be randomized, stratified by eGFR (<30 versus ≥ 30) to an exercise intervention or usual care. The main outcome is the difference in 24-hour ambulatory SBP after eight weeks of exercise training between groups. Secondary outcomes include: BPs at eight and 24 weeks, dose of anti-hypertensives, aortic stiffness, CV-risk markers, CV fitness, 7-day accelerometry, quality of life, safety, and in an exploratory analysis, eGFR and proteinuria. The intervention is thrice weekly moderate intensity aerobic exercise supplemented with isometric resistance exercise, targeting 150 minutes per week and delivered over 24-weeks. Phase 1: one supervised weekly sessions and home-based sessions (eight weeks). Phase 2: home-based sessions (16 weeks). To detect a clinically important BP reduction of 5 mmHg between groups requires 128 patients (two sample t-test, alpha 0.05, beta 0.2, common standard deviation of 10 mmHg). Assuming 20% dropout requires 160 patients. For the primary outcome, the investigators will use a mixed linear regression model in which BP is regressed on group, baseline SBP and eGFR, and time point.
Expected outcomes: The findings from this study will address a significant knowledge gap in hypertension management in CKD, inform care-delivery and the design of a larger study on CKD progression. This proposal aligns with priorities for both patients and decision makers: to identify the role of exercise in CKD management and to reshape the delivery of renal care so that it is more consistent with patient values and preferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this parallel arm control trial, participants recruited from outpatient CKD clinics in Alberta Kidney Care North, Edmonton, Alberta, Canada will be randomized (1:1) to enhanced usual care (measurement of physical activity levels) or an exercise intervention.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExercisePersonnel experienced in training people with chronic conditions (exercise specialist) will supervise the exercise training. At each in-center session in phase 1, the patient's exercise will be monitored to assess whether they are achieving target levels. Training intensities will be prescribed based on the most recent exercise test. Phase 1: an eight-week program of once weekly-supervised facility-based exercise sessions and twice weekly home-based sessions. Phase 2: a 16-week home-based exercise program overseen by an exercise specialist. During this phase, participants will be progressed through their home-based exercise program from Phase 1 on an individual basis. i. Frequency. A minimum of three exercise sessions per week. ii. Intensity. A moderate intensity (40-60% heart rate reserve) based on exercise testing. iii. Time. 150 minutes of exercise per week. iv. Type. We will prescribe aerobic exercise supplemented with isometric resistance exercises. |
| Enhanced usual care | Other | Other: Enhanced usual careParticipants in the control group will perform accelerometry. This is enhanced usual care because physical activity measurement is not routinely performed in CKD clinics. Control arm participants will only receive their accelerometry data after they have completed the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Resting SBP >120 mmHg systolic on screening BP clinic measurements (with an electronic sphygmomanometer, mean of three readings after first reading is discarded) and at least one previous SBP measurement above 120 mmHg on a separate occasion within the past six months (home or clinic measurement).
- Stable on blood pressure medications for the past eight weeks
- eGFR 15-44 ml/min per 1.73m2 eGFR between 15-44 ml/min per 1.73m2 within the last three months and one additional value in this rage in the last 12 months.
- Independent ambulation with or without an assistive device for at least three consecutive minutes
- Cognition and English language sufficient enough to understand written information, provide consent, and comply with the testing and interventions
Key exclusion criteria (12 listed)
- Resting SBP >160 mmHg or DBP > 110 mmHg on screening BP clinic measurement (Note: the individual may be re-screened 8 weeks after medication adjustment)
- Arm circumference greater than 54 centimeters (size limit of large ABPM cuff)
- Recent (<6 weeks) or planned (<6 months) major cardiovascular events or procedures
- Any known contraindication to exercise (American College of Sports Medicine Guidelines)
- Acute myocardial infarction (3-5 days) or unstable angina; Uncontrolled symptomatic arrhythmias; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Acute pulmonary embolism or deep vein thrombosis; Suspected dissecting aneurysm; Uncontrolled asthma; Uncontrolled pulmonary edema; Room air desaturation to <85%; Acute non-cardiopulmonary disorder that may affect exercise performance (infection, orthopedic problem); Mental impairment leading to inability to cooperate; Uncontrolled hypertension (as above)
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 |
|---|---|---|
| ExerciseSee previous description | Behavioural | Exercise |
| Enhanced usual careSee previous description | Other | Enhanced usual care |
Primary outcome
24-hour ambulatory SBP
Time frame: 8 weeks
mean 24-hour ambulatory systolic blood pressure
30 secondary outcomes
antihypertensive use
Time frame: 8 and 24 weeks
KDQOL-36
Time frame: 8 and 24 weeks
IPAQ-SF
Time frame: 8 and 24 weeks
SEE scale
Time frame: 8 and 24 weeks
EQ-5D
Time frame: 8 and 24 weeks
pulse wave velocity
Time frame: 8 and 24 weeks
body mass index
Time frame: 8 and 24 weeks
Fat mass
Time frame: 8 and 24 weeks
clinic blood pressure
Time frame: 8 and 24 weeks
Oxygen uptake (VO2 peak)
Time frame: 8 and 24 weeks
estimated glomerular filtration rate
Time frame: 8 and 24 weeks
c-reactive protein
Time frame: 8 and 24 weeks
total cholesterol
Time frame: 8 and 24 weeks
LDL
Time frame: 8 and 24 weeks
HDL
Time frame: 8 and 24 weeks
triglycerides
Time frame: 8 and 24 weeks
HgA1C
Time frame: 24 weeks
spot urinary sodium
Time frame: 8 and 24 weeks
spot urinary protein
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
7-day accelerometry
Time frame: 8 and 24 weeks
24-hour ABPM
Time frame: 8 and 24 weeks
Adherence
Time frame: 8 and 24 weeks
Body cell mass
Time frame: 8 and 24 weeks
Results and safety
The study was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 30736832Thompson S, Wiebe N, Gyenes G, Davies R, Radhakrishnan J, Graham M. Physical Activity In Renal Disease (PAIRED) and the effect on hypertension: study protocol for a randomized controlled trial. Trials. 2019 Feb 8;20(1):109. doi: 10.1186/s13063-019-3235-5.
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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.
Stephanie Thompson, MD PhD principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise in people with Chronic Kidney Diseases, run by University of Alberta at 3 sites in Canada.
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 12 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: stopped early, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
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?
24-hour ambulatory SBP (time frame: 8 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 NCT03551119, which also lists 1 linked publication.
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 30 Apr 2021.