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

Phase 4

Completed

• Conditions: Chronic Kidney Diseases; Hyperkalemia
• Interventions: Drug: Patiromer; Dietary Supplement: Research Diet Menu

• Registration Number: NCT03183778
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Study Start: 2018-03-12
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Results First Submitted: 2021-09-30
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Results First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patiromer + Research Diet	Patiromer	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.
Patiromer + Research Diet	Research Diet Menu	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.

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP)	Baseline, Week 4
Change in Diastolic Blood Pressure (DBP)	Baseline, Week 4
Change in Fasting Serum Potassium Concentrations	Baseline, Week 4

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States