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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03183778
Other study ID # 17-00051
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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