Evaluation of Increased Fruits and Vegetables Consumption in Chronic Kidney Disease

Nand Wadhwa

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases

Treatments: Other: Fruits and Vegetable increase

Study type: Interventional

Funder types: Other

Identifiers

NCT05050110

NYH-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

chronic kidney disease patients

Other group

Description:

Evaluation of Increased fruits and vegetables consumption in chronic kidney disease patients maintaining normokalemia with patiromer

Treatment:

Other: Fruits and Vegetable increase