NCT03183778

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-12
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2017-06-12
• Last updated: 2021-12-01
• Results posted: 2021-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study