Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.

NCT ID: NCT03183778

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2019-08-01

Brief Summary

The purpose of this proof-of-concept controlled-feeding study is to determine whether patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a plant-rich diet.

Conditions

Chronic Kidney Diseases; Hyperkalemia

Keywords

Chronic kidney disease, stages 3B-4

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patiromer + Research Diet

During the first phase (week 2), participants will be transitioned to a plant-rich renal diet, which contains moderate protein (10-15% of kcal), restricts dairy products (less than or equal to 1 serving/day), and eliminates high-potassium fruits and vegetables.

During the second phase (weeks 3 and 4), the diet will be altered to provide at-least half of fruits and vegetables from high-potassium sources.

Group Type: EXPERIMENTAL

Patiromer

Intervention Type: DRUG

Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.

Research Diet Menu

Intervention Type: DIETARY_SUPPLEMENT

During the study, participants will be asked to consume only the foods provided in the research diet

Interventions

Patiromer

Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.

Intervention Type: DRUG

Research Diet Menu

During the study, participants will be asked to consume only the foods provided in the research diet

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Veltassa

Eligibility Criteria

Inclusion Criteria

• Stages 3B-4 CKD (estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73m2, not treated with dialysis)
• No prior treatment with patiromer
• Mild hyperkalemia (potassium 5.1 to <6.5 mEq/L) on one of the last two blood tests
• No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6 months
• Deemed appropriate for the intervention by the patient's nephrologist, considering the patient's prognosis, cognition and pending treatments (e.g., dialysis)

Exclusion Criteria

• Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors, diuretics, β-blockers) in the last month
• Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery, short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic diarrhea)
• Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to study diets (excludes dietary restrictions on high-potassium foods)
• Pregnant (females) or planning to become pregnant (males and females) during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Goldfarb, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-00051

Identifier Type: -

Identifier Source: org_study_id