Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease

Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease Patients Maintaining Normokalemia With Patiromer

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Fruits and Vegetable increase

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Stahl; Phone Number: 631-675-5075; Email: mstahl@nycancer.com
• Study Contact Backup: Name: Laura Brady; Phone Number: 631-675-5075; Email: lbrady@nycancer.com

Study Locations

• United States
  • New York
    • Port Jefferson Station, New York, United States, 11776
      • Recruiting
      • NY Health
      • Contact: Megan Stahl; Phone Number: 631-675-5075; Email: mstahl@nycancer.com
      • Contact: Laura Brady; Phone Number: 631-675-5075; Email: lbrady@nycancer.com
      • Principal Investigator: Nand Wadwha, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: chronic kidney disease patients; Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer	Other: Fruits and Vegetable increase; Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will increase the Fruit and vegetable consumption by following a Diet plan listed in the Nutritional Diary provided to them by the study site in the beginning of the study while taking Patiromer (Veltassa). This will record their daily intake of 26-28 servings of fruit and vegetables weekly. The Nutritional diary lists a Diet Plan that measures the serving size of 26-28 servings of the fruits and vegetables. The measurement of fruits and vegetables has been calculated by the Nutritionist based off of the USDA Nutritive Value of foods and listed on the diary to explain the serving sizes and suggestions of meal plans.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Kidney Function levels will be tested at each visit from blood samples provided by the subject.	The Kidney Function blood test samples will be taken from the subject to show overall kidney health in Chronic Kidney Disease Patients by increasing their fruit and vegetable intake while on patiromer. The blood tests that support this is , Magnesium, phosphorus, iPTH, lipid panel, uric acid, hemoglobin A1C, Vitamin D 25(OH), Vitamin D 1,25(OH), FGF-23 and CBC panel.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the subjects diet intake related to Quality of Life	The subject will complete a Quality of Life Nutritional Questionnaire which is an instrument supported by ncbi to assess quality of life in relation to nutrition.	3 years
Measure the description of Daily bowel moments to test for constipation	Patient will complete a daily bowel Diary based on the Bristol Stool Chart which is a medical aid designed to classify feces into seven groups. The Diary will be provided to the subject to observe and classify their daily bowel movements.	3 years
Urine will be measured to evaluate kidney function in subjects with Chronic kidney disease	Tests will include 24 hour urine & Random for sodium, potassium, chloride, magnesium, phosphorus, calcium, urea nitrogen, creatinine, protein, albumin	3 years
Measure serum Potassium blood levels to remain below 5mmol/L	Serum Potassium levels are measured by blood samples from the subject that consists of either A Comprehensive Metabolic Panel blood test which includes or Basic Metabolic Panel depending on the timepoint in the study.	3 years

Collaborators and Investigators

• Sponsor: Nand Wadhwa
• Investigators: Principal Investigator: Nand Wadwha, MD, NY Health

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: NYH-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No