Chronic Kidney Disease stage4HELPFULNCT04207203
Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study
A study testing sodium zirconium cyclosilicate and healthy diet in people with Chronic Kidney Disease stage4 and Chronic Kidney Disease Stage 5, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with chronic kidney disease (CKD) stages 4 and 5… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Hyperkalemia
- What is being tested?
- sodium zirconium cyclosilicate and healthy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- 3 Nov 2020to 10 May 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 to 85 years; glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who develops hyperkalemia after SPS is ceased.
Who cannot join
- Patients with serum K > 6.5 mmol/ and those likely to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of hypokalemia (<3.0 mmol/L). Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Diet Rich in Potassium Containing Fruits, Vegetables and Nuts to Chronic Kidney Disease Patients Thought the Use of Sodium Zirconium Cyclosilicate: A Feasibility Study
This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be normalized with the use of SZC and then the participants will receive a fruit basket during 3 weeks. SZC will be continued thru out the study. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
Read the detailed description
Feasibility, descriptive single arm open-label interventional trial lasting 6 weeks. The study will recruit 36 CKD patients at the outpatient clinic with: age between 18 to 85 years; glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who develops hyperkalemia after SPS is ceased. Patients with serum K > 6.5 mmol/ and those likely to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of hypokalemia (<3.0 mmol/L) will not be included. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins. Intervention: In the first 3 weeks, representing stabilization phase, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed by a renal dietitian. At the end of the first 3 weeks, the patients will be instructed to keep the diet with same content of energy and initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). In order to increase adherence, a food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient and the family will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. Blood measurements, questionnaires related to quality of life and intestinal obstipation and measurements of nutritional intake will be performed in the beginning and at the end of the stabilization phase and again in the beginning and end of the healthy diet phase. Additionally, during stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.
- Being tested
- sodium zirconium cyclosilicate and healthy diet
- Keywords
- Healthy diet, Quality of life, Uremic toxins, Hyperkalemia, Chronic kidney disease, Gut microbiota
- 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.
sodium zirconium cyclosilicate and healthy dietCombination product
During 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | During 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week. Receives: Combination Product: sodium zirconium cyclosilicate and healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Renal Treatment Satisfaction Questionnaire (RTSQ). It si based on 13 questions, each varying from 0 to 6. Total score is 78, being the highest score the better.
Measured: 6 weeks
Symptoms list
Symptoms list
Measured: 6 weeks
Energy intake
24-hour food recalls
Measured: 6 weeks
Protein intake
24-hour food recalls
Measured: 6 weeks
Secondary outcomes (8)
Plasma potassium
Plasma potassium concentration
Measured: 6 weeks
Short Form Health Survey (SF-36)
Short Form Health Survey (SF-36). It is calculated using norm-based scoring, which employs linear transformation to achieve standardized scores with a mean of 50. the highest, the better.
Measured: 6 weeks
Intestinal obstipation
Bristol stool chart
Measured: 6 weeks
Inflammatory marker 1
C-reactive protein concentration
Measured: 6 weeks
Inflammatory marker 2
Interleukin 6 concentration
Measured: 6 weeks
Microbiota-derived uremic retention solutes 1
P-cresyl sulfate concentration
Measured: 6 weeks
Microbiota-derived uremic retention solutes 2
Indoxyl-sulfate concentration
Measured: 6 weeks
Microbiota-derived uremic retention solutes 3
Trimethylamine N-oxide concentration
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start3 Nov 2020
- Primary completion1 Apr 2023
- Study completion10 May 2023
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 Disease stage4Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In the first 3 weeks, stabilization phase, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Peter Stenvinkel, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207203
- Sponsor's protocol ID
- ESR-18-13936
- Acronym
- HELPFUL
- Status last verified
- May 2023
- First submitted
- 17 Dec 2019
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
Avesani CM, Heimburger O, Rubin C, Sallstrom T, Faxen-Irving G, Lindholm B, Stenvinkel P. Plant-based diet in hyperkalemic chronic kidney disease patients receiving sodium zirconium cyclosilicate: a feasibility clinical trial. Am J Clin Nutr. 2024 Sep;120(3):719-726. doi: 10.1016/j.ajcnut.2024.06.025. Epub 2024 Jul 18.
PubMed 39032787
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Diet Rich in Potassium Containing Fruits, Vegetables and Nuts to Chronic Kidney Disease Patients Thought the Use of Sodium Zirconium Cyclosilicate: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04207203
- Acronym / sponsor ID
- HELPFUL / ESR-18-13936
- Keywords
- Healthy diet, Quality of life, Uremic toxins, Hyperkalemia, Chronic kidney disease, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be normalized with the use of SZC and then the participants will receive a fruit basket during 3 weeks. SZC will be continued thru out the study. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
Detailed description
Feasibility, descriptive single arm open-label interventional trial lasting 6 weeks. The study will recruit 36 CKD patients at the outpatient clinic with: age between 18 to 85 years; glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who develops hyperkalemia after SPS is ceased. Patients with serum K > 6.5 mmol/ and those likely to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of hypokalemia (<3.0 mmol/L) will not be included. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins. Intervention: In the first 3 weeks, representing stabilization phase, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed by a renal dietitian. At the end of the first 3 weeks, the patients will be instructed to keep the diet with same content of energy and initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). In order to increase adherence, a food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient and the family will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. Blood measurements, questionnaires related to quality of life and intestinal obstipation and measurements of nutritional intake will be performed in the beginning and at the end of the stabilization phase and again in the beginning and end of the healthy diet phase. Additionally, during stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the first 3 weeks, stabilization phase, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Combination Product: sodium zirconium cyclosilicate and healthy dietDuring 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 18 to 85 years; glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who develops hyperkalemia after SPS is ceased.
Key exclusion criteria (1 listed)
- Patients with serum K > 6.5 mmol/ and those likely to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of hypokalemia (<3.0 mmol/L). Pregnant women.
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 |
|---|---|---|
| sodium zirconium cyclosilicate and healthy dietDuring 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week. | Combination product | Single arm study |
Primary outcome
Patient satisfaction
Time frame: 6 weeks
Renal Treatment Satisfaction Questionnaire (RTSQ). It si based on 13 questions, each varying from 0 to 6. Total score is 78, being the highest score the better.
Symptoms list
Time frame: 6 weeks
Symptoms list
Energy intake
Time frame: 6 weeks
24-hour food recalls
Protein intake
Time frame: 6 weeks
24-hour food recalls
8 secondary outcomes
Plasma potassium
Time frame: 6 weeks
Short Form Health Survey (SF-36)
Time frame: 6 weeks
Intestinal obstipation
Time frame: 6 weeks
Inflammatory marker 1
Time frame: 6 weeks
Inflammatory marker 2
Time frame: 6 weeks
Microbiota-derived uremic retention solutes 1
Time frame: 6 weeks
Microbiota-derived uremic retention solutes 2
Time frame: 6 weeks
Microbiota-derived uremic retention solutes 3
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Derived from this study: PubMed 39032787Avesani CM, Heimburger O, Rubin C, Sallstrom T, Faxen-Irving G, Lindholm B, Stenvinkel P. Plant-based diet in hyperkalemic chronic kidney disease patients receiving sodium zirconium cyclosilicate: a feasibility clinical trial. Am J Clin Nutr. 2024 Sep;120(3):719-726. doi: 10.1016/j.ajcnut.2024.06.025. Epub 2024 Jul 18.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium zirconium cyclosilicate and healthy diet in people with Chronic Kidney Disease stage4 and Chronic Kidney Disease Stage 5, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT04207203, 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 23 May 2023.