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

NCT03183778 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-00051
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hyperkalemia

Keywords

Chronic kidney disease, stages 3B-4

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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

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.

Also known as: Veltassa

Patiromer + Research Diet

Research Diet Menu DIETARY_SUPPLEMENT

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

Patiromer + Research Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Interventions

patiromer

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: David Goldfarb, MD
• Organization: NYU Langone Health

David.Goldfarb@nyulangone.org

212-263-0744

Study Officials

• David Goldfarb, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: March 12, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-11

Locations

US (1)