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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183778
• Other study ID #: 17-00051
• Status: Completed
• Phase: Phase 4
• Start date: March 12, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: November 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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, ß-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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hyperkalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Dietary Supplement:
• Research Diet Menu
During the study, participants will be asked to consume only the foods provided in the research diet

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fasting Serum Potassium Concentrations		Baseline, Week 2
Primary	Change in Fasting Serum Potassium Concentrations		Baseline, Week 4
Primary	Change in Systolic Blood Pressure (SBP)		Baseline, Week 2
Primary	Change in Systolic Blood Pressure (SBP)		Baseline, Week 4
Primary	Change in Diastolic Blood Pressure (DBP)		Baseline, Week 2
Primary	Change in Diastolic Blood Pressure (DBP)		Baseline, Week 4