Chronic Kidney DiseaseK-HANDLE CKDNCT06920914
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
A study testing Low-potassium, ultra-processed diet, Low-potassium, minimally processed diet and Normal potassium-rich, minimally processed diet in people with Chronic Kidney Disease, run by University of Alberta.
Trial summary
What is this study about? This clinical trial is designed to learn how potassium from different types of food affects blood potassium levels and overall health in people with chronic kidney disease (CKD, stages 3B-5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Low-potassium, ultra-processed diet, Low-potassium, minimally processed diet and Normal potassium-rich, minimally processed diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jun 2028
- Phase
- Interventional
- 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
Who may be able to join
- Participants aged ≥18 years living with stage 3B-5 CKD (estimated glomerular filtration rate ≥ 15 mL/min/1.73m2) on conservative kidney management (not on dialysis).
- Able and willing to follow a controlled feeding regimen, attend in-person visits, provide informed consent, and comply with study procedures.
Who cannot join
- General
- Pregnant or lactating women.
- Transitioning transgender individuals.
- Individuals with strict dietary preferences (e.g., vegetarians, vegans) or allergies/intolerance that would preclude participation in the diet phases.
- Kidney Function
- Foreseen start of renal replacement therapy within the next 6 months.
Show all 37Show fewer
- Acute kidney injury in the past 3 months.
- 2-year Kidney Failure Risk Equation > 40%.
- Preemptive kidney transplant planned within the next 6 months.
- History of kidney transplant.
- Active glomerulonephritis. Comorbidities
- Acute myocardial infarction or stroke within the past 6 months.
- Active cancer.
- Ileostomy, short bowel syndrome or inflammatory bowel disease.
- Body mass index < 18.5 or ≥ 35.
- New York Heart Association Class III or IV congestive heart failure.
- History of ventricular arrhythmia.
- Major surgery within the past 3 months.
- Active autoimmune disease.
- Glycated hemoglobin > 10% within the past 3 months.
- Gastroparesis.
- Chronic nausea and vomiting.
- Intensive care unit admission within the past 3 months.
- Significant psychiatric disease.
- Uncontrolled blood pressure (above 160/100). Current Use of Medications/Supplements
- Immunosuppressives.
- Potassium binders.
- Lithium.
- Motility agents.
- More than 2 medications that inhibit renal potassium excretion (e.g., angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, mineralocorticoid receptor antagonists).
- Supplements known to influence potassium levels. Potassium-Related Conditions
- Potassium > 5.5 mmol/L in more than 3 episodes within the past year.
- Participants with genetic issues affecting potassium handling (e.g. Barter and Liddle syndrome) or other unique health conditions that could interfere with potassium handling.
- Intervention-related Conditions
- Fluid volume status or hypertension being actively managed. Other Factors
- Documented non-adherence to medications or other therapeutic measures.
- Use of tube feeding or parenteral nutrition.
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
Official title: Potassium (K) Handling in Advanced Chronic Kidney Disease (K-HANDLE CKD)
What is this study about?
This clinical trial is designed to learn how potassium from different types of food affects blood potassium levels and overall health in people with chronic kidney disease (CKD, stages 3B-5).
Read more
People with CKD are often advised to avoid potassium-rich foods, even though fresh fruits and vegetables are important for good health. However, potassium in processed foods (such as packaged snacks and ready-made meals) may be absorbed differently than potassium from fresh foods.
This study will compare minimally processed vs. ultra-processed foods to determine how different sources of potassium affect potassium levels and help create better dietary recommendations for people with CKD.
What are the study goals?
The study will answer:
- Does potassium from fresh foods (like fruits and vegetables) affect blood potassium differently than potassium from processed foods?
- How does dietary potassium impact potassium absorption and excretion in people with CKD?
Researchers will compare the effects of four diets to understand how low and normal-potassium rich diets from fresh vs. processed foods influence:
- Blood potassium levels
- Body composition (muscle, fat, and fluid balance)
- Vascular health
What will participants do?
Participants will follow four different 10-day diets over the course of the study. All food will be provided at no cost. These diets are:
- Minimally processed with low-potassium content
- Minimally processed with normal potassium content
- Ultra-processed with with low-potassium content
- Ultra-processed with normal potassium content
There will be 16-day breaks (washout period) between diets where participants return to their normal eating habits.
During the study, participants will:
- Pick up prepared meals from the research center approximately 3 times per week.
- Attend checkups for weight, blood pressure, and blood tests.
- Provide urine samples to track potassium levels.
- Wear a comfortable, cuff-free blood pressure monitor at home.
- Keep a study journal to track diet, medications, and symptoms.
- Complete questionnaires about diet satisfaction and health changes.
- Conditions
- Chronic Kidney Disease
- Being tested
- Low-potassium, ultra-processed diet, Low-potassium, minimally processed diet, Normal potassium-rich, minimally processed diet, Normal potassium-rich, ultra-processed diet
- Keywords
- CKD, Chronic Kidney Disease, potassium, hyperkalemia, hyperkalaemia, minimally processed foods, ultra-processed foods, feeding trial
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-potassium, ultra-processed dietOther
A diet restricted in potassium, primarily composed of industrially processed foods such as packaged snacks and processed meals.
Low-potassium, minimally processed dietOther
A diet restricted in naturally occurring potassium, primarily composed of fresh fruits, vegetables, whole grains, and other minimally processed foods.
Normal potassium-rich, minimally processed dietOther
A diet with normal potassium content, primarily composed of fresh fruits, vegetables, whole grains, and other minimally processed foods, rich in naturally occurring potassium, following a Mediterranean-style pattern.
Normal potassium-rich, ultra-processed dietOther
A diet with normal potassium content, primarily composed of industrially processed foods such as packaged snacks and processed meals
| Study group | Role | What they receive |
|---|---|---|
| Low-potassium, ultra-processed diet | Experimental | Participants in this group will follow a diet consisting of ultra-processed foods with restricted potassium content. Receives: Other: Low-potassium, ultra-processed diet |
| Normal potassium-rich, minimally processed diet | Experimental | Participants in this group will follow a diet consisting of minimally processed foods with a normal potassium content. Receives: Other: Normal potassium-rich, minimally processed diet |
| Normal potassium-rich, ultra-processed diet | Experimental | Participants in this group will follow a diet consisting of ultra-processed foods with a normal potassium content. Receives: Other: Normal potassium-rich, ultra-processed diet |
| Low-potassium, minimally processed diet | Experimental | Participants in this group will follow a diet consisting of minimally processed foods with restricted potassium content. Receives: Other: Low-potassium, minimally processed diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Serum Potassium Levels (mmol/L)
This measure assesses the concentration of potassium in participants' blood after fasting overnight. Normal potassium levels typically range from 3.5 to 5.0 mmol/L.
Measured: Days 10, 36, 62, and 88.
Secondary outcomes (6)
Postprandial Whole-Blood Potassium Response (mmol/L)
This measure examines changes in blood potassium levels after a standardized test meal. Blood samples are collected before the meal (baseline) and at regular intervals (15, 30, 60, 90, 120, 150, and 180 minutes) to calculate the area under the curve (AUC), which reflects the total potassium response over time.
Measured: 15, 30, 60, 90, 120, 150, 180 minutes post-meal at days 10, 36, 62, and 88.
Potassium Bioavailability
Potassium bioavailability is assessed by measuring the potassium content in 24-hour urine samples. This provides insights into how much potassium from the diet is absorbed and how much is excreted by the body.
Measured: Days 7-9, 33-35, 59-61, 85-87.
Body Composition (kg)
This measure estimates participants' fat mass and fat-free mass. Body composition is assessed using bioelectrical impedance analysis, which uses safe, low-level electrical currents to estimate tissue and fluid distribution. Results are reported in kilograms (kg).
Measured: Baseline and days 10, 36, 62, and 88.
Body water (L)
This measure evaluates fluid status, i which plays a role in potassium handling. Body water is estimated using bioelectrical impedance analysis, which uses safe, low-level electrical currents to estimate tissue and fluid distribution. Results are reported in liters for total, extracellular, and intracellular water.
Measured: Baseline and days 10, 36, 62, and 88.
24h blood pressure (mmHg)
Systolic and diastolic blood pressure will be monitored for 24h.
Measured: Days 8-10, 34-36, 60-62, and 86-88.
Dietary Satisfaction Questionnaire
Self-administered questionnaire to provide feedback on the palatability, variety, and overall acceptability of the study-provided diets.
Measured: Days 10, 36, 62, and 88.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Caroline Richard, PhD, Principal investigator, University of AlbertaBranko Braam, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920914
- Sponsor's protocol ID
- Pro00139586
- Other IDs
- RES0062629
- Acronym
- K-HANDLE CKD
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have not yet finalized a plan for sharing individual participant data. The decision will depend on several factors, including participant consent, ethical approval, and institutional policies regarding data privacy and security. Future data sharing may be considered upon additional ethical review and participant consent.
Publications
Picard K, Barreto Silva MI, Mager D, Richard C. Dietary Potassium Intake and Risk of Chronic Kidney Disease Progression in Predialysis Patients with Chronic Kidney Disease: A Systematic Review. Adv Nutr. 2020 Jul 1;11(4):1002-1015. doi: 10.1093/advances/nmaa027.
PubMed 32191264Picard K, Mager DR, Senior PA, Richard C. Potassium-Based Sodium Substitutes Impact the Sodium and Potassium Content of Foods. J Ren Nutr. 2025 Jan;35(1):64-71. doi: 10.1053/j.jrn.2024.05.010. Epub 2024 Jun 6.
PubMed 38848804Picard K. Potassium Additives and Bioavailability: Are We Missing Something in Hyperkalemia Management? J Ren Nutr. 2019 Jul;29(4):350-353. doi: 10.1053/j.jrn.2018.10.003. Epub 2018 Dec 19.
PubMed 30579674Picard K, Picard C, Mager DR, Richard C. Potassium content of the American food supply and implications for the management of hyperkalemia in dialysis: An analysis of the Branded Product Database. Semin Dial. 2024 Jul-Aug;37(4):307-316. doi: 10.1111/sdi.13007. Epub 2021 Jul 29.
PubMed 34323307Picard K RD BSc, Senior PA MBBS PhD FRCP(E) FRCP, Wilmott A BSc, Jindal K MD FRCPC, Richard C RD PhD, Mager DR RD PhD. Comparison of diet quality tools to assess nutritional adequacy for adults living with kidney disease. Can J Diet Pract Res. 2022 Dec 1;83(4):180-185. doi: 10.3148/cjdpr-2022-009. Epub 2022 May 3.
PubMed 35503893Picard K, Senior PA, Adame Perez S, Jindal K, Richard C, Mager DR. Low Mediterranean Diet scores are associated with reduced kidney function and health related quality of life but not other markers of cardiovascular risk in adults with diabetes and chronic kidney disease. Nutr Metab Cardiovasc Dis. 2021 May 6;31(5):1445-1453. doi: 10.1016/j.numecd.2021.02.002. Epub 2021 Feb 11.
PubMed 33812736Picard K, Griffiths M, Mager DR, Richard C. Handouts for Low-Potassium Diets Disproportionately Restrict Fruits and Vegetables. J Ren Nutr. 2021 Mar;31(2):210-214. doi: 10.1053/j.jrn.2020.07.001. Epub 2020 Aug 20.
PubMed 32830022
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium (K) Handling in Advanced Chronic Kidney Disease (K-HANDLE CKD)
- ClinicalTrials.gov ID
- NCT06920914
- Acronym / sponsor ID
- K-HANDLE CKD / Pro00139586
- Conditions
- Chronic Kidney Disease
- Keywords
- CKD, Chronic Kidney Disease, potassium, hyperkalemia, hyperkalaemia, minimally processed foods, ultra-processed foods, feeding trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Apr 2025 (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.
What is this study about?
This clinical trial is designed to learn how potassium from different types of food affects blood potassium levels and overall health in people with chronic kidney disease (CKD, stages 3B-5).
People with CKD are often advised to avoid potassium-rich foods, even though fresh fruits and vegetables are important for good health. However, potassium in processed foods (such as packaged snacks and ready-made meals) may be absorbed differently than potassium from fresh foods.
This study will compare minimally processed vs. ultra-processed foods to determine how different sources of potassium affect potassium levels and help create better dietary recommendations for people with CKD.
What are the study goals?
The study will answer:
- Does potassium from fresh foods (like fruits and vegetables) affect blood potassium differently than potassium from processed foods?
- How does dietary potassium impact potassium absorption and excretion in people with CKD?
Researchers will compare the effects of four diets to understand how low and normal-potassium rich diets from fresh vs. processed foods influence:
- Blood potassium levels
- Body composition (muscle, fat, and fluid balance)
- Vascular health
What will participants do?
Participants will follow four different 10-day diets over the course of the study. All food will be provided at no cost. These diets are:
- Minimally processed with low-potassium content
- Minimally processed with normal potassium content
- Ultra-processed with with low-potassium content
- Ultra-processed with normal potassium content
There will be 16-day breaks (washout period) between diets where participants return to their normal eating habits.
During the study, participants will:
- Pick up prepared meals from the research center approximately 3 times per week.
- Attend checkups for weight, blood pressure, and blood tests.
- Provide urine samples to track potassium levels.
- Wear a comfortable, cuff-free blood pressure monitor at home.
- Keep a study journal to track diet, medications, and symptoms.
- Complete questionnaires about diet satisfaction and health changes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-potassium, ultra-processed diet | Experimental | Other: Low-potassium, ultra-processed dietParticipants in this group will follow a diet consisting of ultra-processed foods with restricted potassium content. |
| Normal potassium-rich, minimally processed diet | Experimental | Other: Normal potassium-rich, minimally processed dietParticipants in this group will follow a diet consisting of minimally processed foods with a normal potassium content. |
| Normal potassium-rich, ultra-processed diet | Experimental | Other: Normal potassium-rich, ultra-processed dietParticipants in this group will follow a diet consisting of ultra-processed foods with a normal potassium content. |
| Low-potassium, minimally processed diet | Experimental | Other: Low-potassium, minimally processed dietParticipants in this group will follow a diet consisting of minimally processed foods with restricted potassium content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants aged ≥18 years living with stage 3B-5 CKD (estimated glomerular filtration rate ≥ 15 mL/min/1.73m2) on conservative kidney management (not on dialysis).
- Able and willing to follow a controlled feeding regimen, attend in-person visits, provide informed consent, and comply with study procedures.
Key exclusion criteria (37 listed)
- General
- Pregnant or lactating women.
- Transitioning transgender individuals.
- Individuals with strict dietary preferences (e.g., vegetarians, vegans) or allergies/intolerance that would preclude participation in the diet phases.
- Kidney Function
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 |
|---|---|---|
| Low-potassium, ultra-processed dietA diet restricted in potassium, primarily composed of industrially processed foods such as packaged snacks and processed meals. | Other | Low-potassium, ultra-processed diet |
| Low-potassium, minimally processed dietA diet restricted in naturally occurring potassium, primarily composed of fresh fruits, vegetables, whole grains, and other minimally processed foods. | Other | Low-potassium, minimally processed diet |
| Normal potassium-rich, minimally processed dietA diet with normal potassium content, primarily composed of fresh fruits, vegetables, whole grains, and other minimally processed foods, rich in naturally occurring potassium, following a Mediterranean-style pattern. | Other | Normal potassium-rich, minimally processed diet |
| Normal potassium-rich, ultra-processed dietA diet with normal potassium content, primarily composed of industrially processed foods such as packaged snacks and processed meals | Other | Normal potassium-rich, ultra-processed diet |
Primary outcome
Fasting Serum Potassium Levels (mmol/L)
Time frame: Days 10, 36, 62, and 88.
This measure assesses the concentration of potassium in participants' blood after fasting overnight. Normal potassium levels typically range from 3.5 to 5.0 mmol/L.
6 secondary outcomes
Postprandial Whole-Blood Potassium Response (mmol/L)
Time frame: 15, 30, 60, 90, 120, 150, 180 minutes post-meal at days 10, 36, 62, and 88.
Potassium Bioavailability
Time frame: Days 7-9, 33-35, 59-61, 85-87.
Body Composition (kg)
Time frame: Baseline and days 10, 36, 62, and 88.
Body water (L)
Time frame: Baseline and days 10, 36, 62, and 88.
24h blood pressure (mmHg)
Time frame: Days 8-10, 34-36, 60-62, and 86-88.
Dietary Satisfaction Questionnaire
Time frame: Days 10, 36, 62, and 88.
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 26 Oct 2026.
- Background: PubMed 32191264Picard K, Barreto Silva MI, Mager D, Richard C. Dietary Potassium Intake and Risk of Chronic Kidney Disease Progression in Predialysis Patients with Chronic Kidney Disease: A Systematic Review. Adv Nutr. 2020 Jul 1;11(4):1002-1015. doi: 10.1093/advances/nmaa027.
- Background: PubMed 38848804Picard K, Mager DR, Senior PA, Richard C. Potassium-Based Sodium Substitutes Impact the Sodium and Potassium Content of Foods. J Ren Nutr. 2025 Jan;35(1):64-71. doi: 10.1053/j.jrn.2024.05.010. Epub 2024 Jun 6.
- Background: PubMed 30579674Picard K. Potassium Additives and Bioavailability: Are We Missing Something in Hyperkalemia Management? J Ren Nutr. 2019 Jul;29(4):350-353. doi: 10.1053/j.jrn.2018.10.003. Epub 2018 Dec 19.
- Background: PubMed 34323307Picard K, Picard C, Mager DR, Richard C. Potassium content of the American food supply and implications for the management of hyperkalemia in dialysis: An analysis of the Branded Product Database. Semin Dial. 2024 Jul-Aug;37(4):307-316. doi: 10.1111/sdi.13007. Epub 2021 Jul 29.
- Background: PubMed 35503893Picard K RD BSc, Senior PA MBBS PhD FRCP(E) FRCP, Wilmott A BSc, Jindal K MD FRCPC, Richard C RD PhD, Mager DR RD PhD. Comparison of diet quality tools to assess nutritional adequacy for adults living with kidney disease. Can J Diet Pract Res. 2022 Dec 1;83(4):180-185. doi: 10.3148/cjdpr-2022-009. Epub 2022 May 3.
- Background: PubMed 33812736Picard K, Senior PA, Adame Perez S, Jindal K, Richard C, Mager DR. Low Mediterranean Diet scores are associated with reduced kidney function and health related quality of life but not other markers of cardiovascular risk in adults with diabetes and chronic kidney disease. Nutr Metab Cardiovasc Dis. 2021 May 6;31(5):1445-1453. doi: 10.1016/j.numecd.2021.02.002. Epub 2021 Feb 11.
- Background: PubMed 32830022Picard K, Griffiths M, Mager DR, Richard C. Handouts for Low-Potassium Diets Disproportionately Restrict Fruits and Vegetables. J Ren Nutr. 2021 Mar;31(2):210-214. doi: 10.1053/j.jrn.2020.07.001. Epub 2020 Aug 20.
- Individual participant dataSharing planned: No. We have not yet finalized a plan for sharing individual participant data. The decision will depend on several factors, including participant consent, ethical approval, and institutional policies regarding data privacy and security. Future data sharing may be considered upon additional ethical review and participant consent.
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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.
Caroline Richard, PhD principal investigator
University of Alberta
Branko Braam, MD, PhD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A study testing Low-potassium, ultra-processed diet, Low-potassium, minimally processed diet and Normal potassium-rich, minimally processed diet in people with Chronic Kidney Disease, run by University of Alberta.
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 2 inclusion and 37 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 26 Oct 2026. 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 Jenneffer Rayane Braga Tibaes, PhD (7804929506, bragatib@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Serum Potassium Levels (mmol/L) (time frame: Days 10, 36, 62, and 88.). 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 NCT06920914, which also lists 7 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 26 Oct 2026.