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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03183778
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases; Hyperkalemia	Drug: Patiromer; Dietary Supplement: Research Diet Menu	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
• Actual Study Start Date: Mar 12, 2018
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Patiromer + Research Diet 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.

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.; Other Names: Veltassa ; Dietary Supplement: Research Diet Menu; During the study, participants will be asked to consume only the foods provided in the research diet

Outcome Measures

Primary Outcome Measures

1. Change in Fasting Serum Potassium Concentrations [Baseline, Week 2]

2. Change in Fasting Serum Potassium Concentrations [Baseline, Week 4]

3. Change in Systolic Blood Pressure (SBP) [Baseline, Week 2]

4. Change in Systolic Blood Pressure (SBP) [Baseline, Week 4]

5. Change in Diastolic Blood Pressure (DBP) [Baseline, Week 2]

6. Change in Diastolic Blood Pressure (DBP) [Baseline, Week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: David Goldfarb, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 10, 2019

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03183778
• Other Study ID Numbers: 17-00051
• First Posted: Jun 12, 2017
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• 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
• Keywords provided by NYU Langone Health: Chronic kidney disease, stages 3B-4
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia

Study Results

Participant Flow

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Period Title: Overall Study
STARTED	3
COMPLETED	2
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Overall Participants	2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74 (6)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 50%
Not Hispanic or Latino	1 50%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 50%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	1 50%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Change in Fasting Serum Potassium Concentrations
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Measure Participants	2
Mean (Standard Deviation) [mg/dL]	-0.2 (0.14)

2. Primary Outcome

Title	Change in Fasting Serum Potassium Concentrations
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Measure Participants	2
Mean (Standard Deviation) [mg/dL]	0.7 (0.57)

3. Primary Outcome

Title	Change in Systolic Blood Pressure (SBP)
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Measure Participants	2
Mean (Standard Deviation) [mmHg]	-13 (2.8)

4. Primary Outcome

Title	Change in Systolic Blood Pressure (SBP)
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Measure Participants	2
Mean (Standard Deviation) [mmHg]	-14.9 (11.9)

5. Primary Outcome

Title	Change in Diastolic Blood Pressure (DBP)
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Measure Participants	2
Mean (Standard Deviation) [mmHg]	-5.5 (2.1)

6. Primary Outcome

Title	Change in Diastolic Blood Pressure (DBP)
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
Measure Participants	2
Mean (Standard Deviation) [mmHg]	-4.3 (4)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Patiromer + Research Diet
Arm/Group 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. 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. Research Diet Menu: During the study, participants will be asked to consume only the foods provided in the research diet
All Cause Mortality
	Patiromer + Research Diet
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Patiromer + Research Diet
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Patiromer + Research Diet
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.