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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03183778

Enrollment

Registered

2017-06-12

Start date

2018-03-12

Completion date

2019-08-01

Last updated

2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Hyperkalemia

Keywords

Chronic kidney disease, stages 3B-4

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.

Interventions

DRUGPatiromer

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_SUPPLEMENTResearch Diet Menu

During the study, participants will be asked to consume only the foods provided in the research diet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Fasting Serum Potassium Concentrations	Baseline, Week 2
Change in Systolic Blood Pressure (SBP)	Baseline, Week 2
Change in Diastolic Blood Pressure (DBP)	Baseline, Week 2

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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	2
Total	2

Arm

Count

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. 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

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawn by Investigator (potassium in normal range)	1

Baseline characteristics

Characteristic	Patiromer + Research Diet
Age, Continuous	74 years STANDARD_DEVIATION 6
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	2 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 2
other Total, other adverse events	0 / 2
serious Total, serious adverse events	0 / 2

Outcome results

Primary

Change in Diastolic Blood Pressure (DBP)

Time frame: Baseline, Week 2

Arm	Measure	Value (MEAN)	Dispersion
Patiromer + Research Diet	Change in Diastolic Blood Pressure (DBP)	-5.5 mmHg	Standard Deviation 2.1

Primary

Change in Diastolic Blood Pressure (DBP)

Time frame: Baseline, Week 4

Arm	Measure	Value (MEAN)	Dispersion
Patiromer + Research Diet	Change in Diastolic Blood Pressure (DBP)	-4.3 mmHg	Standard Deviation 4

Primary

Change in Fasting Serum Potassium Concentrations

Time frame: Baseline, Week 4

Arm	Measure	Value (MEAN)	Dispersion
Patiromer + Research Diet	Change in Fasting Serum Potassium Concentrations	0.7 mg/dL	Standard Deviation 0.57

Primary

Change in Fasting Serum Potassium Concentrations

Time frame: Baseline, Week 2

Arm	Measure	Value (MEAN)	Dispersion
Patiromer + Research Diet	Change in Fasting Serum Potassium Concentrations	-0.2 mg/dL	Standard Deviation 0.14

Primary

Change in Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 2

Arm	Measure	Value (MEAN)	Dispersion
Patiromer + Research Diet	Change in Systolic Blood Pressure (SBP)	-13 mmHg	Standard Deviation 2.8

Primary

Change in Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 4

Arm	Measure	Value (MEAN)	Dispersion
Patiromer + Research Diet	Change in Systolic Blood Pressure (SBP)	-14.9 mmHg	Standard Deviation 11.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change in Diastolic Blood Pressure (DBP)

Change in Diastolic Blood Pressure (DBP)

Change in Fasting Serum Potassium Concentrations

Change in Fasting Serum Potassium Concentrations

Change in Systolic Blood Pressure (SBP)

Change in Systolic Blood Pressure (SBP)