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Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study (HELPFUL)

Primary Purpose

Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Hyperkalemia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
sodium zirconium cyclosilicate and healthy diet
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease stage4 focused on measuring Healthy diet, Quality of life, Uremic toxins, Hyperkalemia, Chronic kidney disease, Gut microbiota

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm study

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Symptoms list
Symptoms list
Energy intake
24-hour food recalls
Protein intake
24-hour food recalls

Secondary Outcome Measures

Plasma potassium
Plasma potassium concentration
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.
Intestinal obstipation
Bristol stool chart
Inflammatory marker 1
C-reactive protein concentration
Inflammatory marker 2
Interleukin 6 concentration
Microbiota-derived uremic retention solutes 1
P-cresyl sulfate concentration
Microbiota-derived uremic retention solutes 2
Indoxyl-sulfate concentration
Microbiota-derived uremic retention solutes 3
Trimethylamine N-oxide concentration

Full Information

First Posted
December 17, 2019
Last Updated
May 20, 2023
Sponsor
Karolinska Institutet
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04207203
Brief Title
Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study
Acronym
HELPFUL
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Hyperkalemia
Keywords
Healthy diet, Quality of life, Uremic toxins, Hyperkalemia, Chronic kidney disease, Gut microbiota

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
sodium zirconium cyclosilicate and healthy diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
6 weeks
Title
Symptoms list
Description
Symptoms list
Time Frame
6 weeks
Title
Energy intake
Description
24-hour food recalls
Time Frame
6 weeks
Title
Protein intake
Description
24-hour food recalls
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Plasma potassium
Description
Plasma potassium concentration
Time Frame
6 weeks
Title
Short Form Health Survey (SF-36)
Description
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.
Time Frame
6 weeks
Title
Intestinal obstipation
Description
Bristol stool chart
Time Frame
6 weeks
Title
Inflammatory marker 1
Description
C-reactive protein concentration
Time Frame
6 weeks
Title
Inflammatory marker 2
Description
Interleukin 6 concentration
Time Frame
6 weeks
Title
Microbiota-derived uremic retention solutes 1
Description
P-cresyl sulfate concentration
Time Frame
6 weeks
Title
Microbiota-derived uremic retention solutes 2
Description
Indoxyl-sulfate concentration
Time Frame
6 weeks
Title
Microbiota-derived uremic retention solutes 3
Description
Trimethylamine N-oxide concentration
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
14134
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers

Learn more about this trial

Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study

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