Use of Patiromer to Transition Chronic Kidney Disease Pat... | NCT03183778

Use of Patiromer to Transition Chronic Kidney Disease Pat... | NCT03183778 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patiromer + Research Diet	Experimental	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 Dietary Supplement: Research Diet Menu

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patiromer	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Fasting Serum Potassium Concentrations		Baseline, Week 2
Change in Fasting Serum Potassium Concentrations		Baseline, Week 4
Change in Systolic Blood Pressure (SBP)		Baseline, Week 2
Change in Systolic Blood Pressure (SBP)		Baseline, Week 4
Change in Diastolic Blood Pressure (DBP)		Baseline, Week 2
Change in Diastolic Blood Pressure (DBP)		Baseline, Week 4

Contacts/Locations Module

Name	Affiliation	Role
David Goldfarb, MD	NYU Langone Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

Arm/Group Information

ID	Title	Description
FG000	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

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects
COMPLETED		FG0002 subjects
NOT COMPLETED		FG0001 subjects

Type	Comment	Reasons
Withdrawn by Investigator (potassium in normal range)		FG0001 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Fasting Serum Potassium Concentrations

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 2

ID	Title	Description
OG000	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
David Goldfarb, MD	NYU Langone Health	212-263-0744		David.Goldfarb@nyulangone.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 10, 2019	Sep 30, 2021	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D051436	Renal Insufficiency, Chronic
D006947	Hyperkalemia

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
C568789	patiromer

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000
Native Hawaiian or Other Pacific Islander	BG0000
Black or African American	BG0001
White	BG0000
More than one race	BG0000
Unknown or Not Reported	BG0001

Primary

Change in Fasting Serum Potassium Concentrations

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 4

ID	Title	Description
OG000	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

Units	Counts
Participants	OG0002

Title

Denominators

Categories

Title	Measurements
	OG0000.7± 0.57

Primary

Change in Systolic Blood Pressure (SBP)

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 2

ID	Title	Description
OG000	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

Units	Counts
Participants	OG0002

Title

Denominators

Categories

Title	Measurements
	OG000-13± 2.8

Primary

Change in Systolic Blood Pressure (SBP)

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 4

ID	Title	Description
OG000	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

Units	Counts
Participants	OG0002

Title

Denominators

Categories

Title	Measurements
	OG000-14.9± 11.9

Primary

Change in Diastolic Blood Pressure (DBP)

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 2

ID	Title	Description
OG000	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

Units	Counts
Participants	OG0002

Title

Denominators

Categories

Title	Measurements
	OG000-5.5± 2.1

Primary

Change in Diastolic Blood Pressure (DBP)

Posted

Mean

Standard Deviation

mmHg

Baseline, Week 4

ID	Title	Description
OG000	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

Units	Counts
Participants	OG0002

Title

Denominators

Categories

Title	Measurements
	OG000-4.3± 4