Clinical trial NCT05050110: Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease
Official title: Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease Patients Maintaining Normokalemia With Patiromer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: NY Health d/b/a New York Cancer and Blood Specialists
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the feasibility of increasing dietary consumption of a rich variety of fruits and vegetables (including those that are potassim-rich) in patients with chronic kidney disease through use of nutritional counselling and hyperkalemia management with patiromer

Detailed description: Adult Patients ages 18 and older with a diagnosis of Chronic Kidney Disease will be given a Diet Plan that consist of an increase of Fruits and Vegetables. Baseline data will be collected after the subject has signed the consent and their most recent eGFR and potassium level that is within 90 days has been reviewed to determine they are within the inclusion criteria.

Based on the approved Patiromer (Veltassa) package insert the subject will begin to take daily. During this control period of two weeks, the subject will document their normal daily consumption of fruits and vegetables in a provided food diary.

On the Second week, patient will receive dietary/nutritional counseling on the importance of potassium-rich fruits and vegetables. They will be instructed to increase their fruit and vegetable intake based on personal preferences and nutritional guides located inside the food diary. Choices will be documented daily in the supplied food diaries.

The Bowel Diary will be classified according to the Bristol Stool Chart and Quality of Life. Nutrition Survey Questionnaire will be documented in that supplied log.

At each subsequent visit, food diaries will be reviewed to evaluate fruit and vegetable consumption, vital signs will be documented and labs collected to measure effects on potassium metabolism. Bowel habits and questionnaires will be completed by the subject to determine how their diet has affected their quality of life.

Patiromer (Veltessa) dosing will be adjusted based on their serum potassium values following the approved drug brochure guidelines and at the discretion of the investigator.

Subject will return to the clinic at specified time points up to 52 weeks on study. The Patient can continue Veltassa while in the follow up period until week 52 at the discretion of the Principle Investigator.

Eligibility criteria: Inclusion Criteria:

1. Adult patients ≥ 18 years of age with chronic kidney disease and hyperkalemia
2. Chronic kidney disease is defined as eGFR 15-44ml/min/1.73m2
3. Documented hyperkalemia which is defined as serum potassium ≥ 5.0 mmol/L during the last 90 days
4. Diet evaluation for hyperkalemia (serum potassium ≥ 5.0) during the last 90 days
5. Patients receiving RASS inhibitors, beta-blockers, or diuretics to be on stable doses for 2 weeks
6. Patients already receiving patiromer are eligible

Exclusion Criteria:

1. Patients with a known allergy to patiromer
2. Patients currently taking other potassium controlling agents.

Primary outcomes:
measure: By increasing the consumption of Fruits and Vegetable in their daily diet using the Nutritional Fruits and Vegetable Diary based off of the USDA Nutritive Value of foods and completing the Quality of Life Nutritional Questionnaire.
timeFrame: 3 years
Secondary outcomes:
measure: The Kidney Function levels will be tested at each visit from blood samples provided by the subject.
timeFrame: 3 years
Other outcomes:
measure: Measure the subjects diet intake related to Quality of Life
timeFrame: 3 years
measure: Measure the description of Daily bowel moments to test for constipation
timeFrame: 3 years
measure: Urine will be measured to evaluate kidney function in subjects with Chronic kidney disease
timeFrame: 3 years
measure: Measure serum Potassium blood levels to remain below 5mmol/L
timeFrame: 3 years
Locations:
city: Port Jefferson Station
country: United States
facility: NY Health
state: New York
Study officials:
affiliation: NY Health
name: Nand Wadwha, MD
role: PRINCIPAL_INVESTIGATOR
References: