Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183778
Recruitment Status : Active, not recruiting
First Posted : June 12, 2017
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
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 : March 12, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Patiromer

Arm Intervention/treatment
Experimental: First Phase
During the first phase (week 1), participants will be transitioned to a plant-rich renal diet, which contains moderate protein (10-15% of kcal), restricts dairy products (1 serving/day), and eliminates high-potassium fruits and vegetables
Drug: Patiromer
Patiromer is a drug used for the treatment of hyperkalemia, a condition that may lead to palpitations and arrhythmia.
Other Name: Veltassa

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

Active Comparator: Second Phase
During the second phase (weeks 2 and 3), the diet will be altered to provide at-least half of fruits and vegetables from high-potassium sources
Drug: Patiromer
Patiromer is a drug used for the treatment of hyperkalemia, a condition that may lead to palpitations and arrhythmia.
Other Name: Veltassa

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




Primary Outcome Measures :
  1. Changes in serum potassium concentrations compared to baseline [ Time Frame: 3 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183778


Locations
Layout table for location information
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: David St Jules, MD NYU Langone Health
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03183778    
Other Study ID Numbers: 17-00051
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

Layout table for additional information
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:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Hyperkalemia
Urologic Diseases
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases