Back to resultsUse of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Primary Purpose
Chronic Kidney Diseases, Hyperkalemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Patiromer
Research Diet Menu
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic kidney disease, stages 3B-4
Eligibility Criteria
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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patiromer + Research Diet
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Fasting Serum Potassium Concentrations
Change in Fasting Serum Potassium Concentrations
Change in Systolic Blood Pressure (SBP)
Change in Systolic Blood Pressure (SBP)
Change in Diastolic Blood Pressure (DBP)
Change in Diastolic Blood Pressure (DBP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183778
Brief Title
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Official Title
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hyperkalemia
Keywords
Chronic kidney disease, stages 3B-4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patiromer + Research Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Patiromer
Other Intervention Name(s)
Veltassa
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Research Diet Menu
Intervention Description
During the study, participants will be asked to consume only the foods provided in the research diet
Primary Outcome Measure Information:
Title
Change in Fasting Serum Potassium Concentrations
Time Frame
Baseline, Week 2
Title
Change in Fasting Serum Potassium Concentrations
Time Frame
Baseline, Week 4
Title
Change in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Week 2
Title
Change in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Week 4
Title
Change in Diastolic Blood Pressure (DBP)
Time Frame
Baseline, Week 2
Title
Change in Diastolic Blood Pressure (DBP)
Time Frame
Baseline, Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goldfarb, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
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