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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Diseases, Hyperkalemia

Intervention / Treatment
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* Drug: Patiromer
* Dietary Supplement: Research Diet Menu


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patiromer + Research Diet<br>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. | Drug: Patiromer<br>* 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.<br>* Other names: Veltassa;Dietary Supplement: Research Diet Menu<br>* During the study, participants will be asked to consume only the foods provided in the research diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Serum Potassium Concentrations |  | Baseline, Week 2 | 
| Change in Fasting Serum Potassium Concentrations |  | Baseline, Week 4 | 
| Change in Systolic Blood Pressure (SBP) |  | Baseline, Week 2 | 
| Change in Systolic Blood Pressure (SBP) |  | Baseline, Week 4 | 
| Change in Diastolic Blood Pressure (DBP) |  | Baseline, Week 2 | 
| Change in Diastolic Blood Pressure (DBP) |  | Baseline, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, stages 3B-4