The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

NCT03326583 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 071738
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.

Conditions

ESRD; Hyperkalemia; End Stage Renal Disease

Keywords

End Stage Renal Disease; ESRD; Hyperkalemia

Outcome Measures

Primary Outcomes (4)

• Adverse Events of Participants Taking Patiromer in Lowering Serum Potassium Levels in End Stage Renal Disease (ESRD) Patients With Hyperkalemia Measured by Gastrointestinal Symptom Rating Scale (GSRS)

  The Gastrointestinal Symptom Rating Scale was used to measures any potential side effects due to study medication. Survey was administered at Wk 1, Wk 8, Wk 14, and Wk 20. For symptoms (abdomen pain - diarrhea) a score of 0 indicates "no discomfort", 1 = "mild discomfort", 2=moderate, 3=severe; higher score means a worse outcome For stool form, 1=Well formed, 2=Semi formed, 3= Loose, 4= Liquid;higher score means a worse outcome For number of stools per day, 1= \<1, 2=1 or 2, 3=3 or 4, 4=5 or 6,5= 7 or more; higher score means a worse outcome

  Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

• Serum Potassium Level Through 12 Weeks of Treatment

  Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20

  Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

• Changes in Blood Chemistry During the Study

  Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

• Stool Electrolytes During the Study Phases

  Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

Secondary Outcomes (2)

• Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer

  Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)

• Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.

  Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)

Study Arms (1)

Patiromer

EXPERIMENTAL

This arm is a 2 week observation period before the start of the Patiromer treatment phase, followed by a 12 week treatment phase, and 6 week no treatment observation phase. Pre-Treatment (Wk 1-2): Observational period. Baseline sample collection of blood and stool. No medication. Treatment (Wk 3-14): Participants will take 8.4 grams of Patiromer once daily for one week, during which serum potassium and gastrointestinal symptoms will be evaluated. If tolerated and in the absence of hypokalemia, the dose will be up-titrated to 16.8 grams once daily for the remaining 11 weeks. Blood and stool will be collected. Post-Treatment (Wk 15-20): Observational period. No medication. Blood and stool will be collected.

Drug: Patiromer

Interventions

Patiromer DRUG

Patiromer will be orally self-administered by participants.

Patiromer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects on stable hemodialysis for more than 90 days.
• Age 18-85 years.
• Persistent hyperkalemia, defined as elevated serum potassium \> 5.0 mEq/L in more than 2 occasions during the previous 3 months.

You may not qualify if:

• Use of pre- or probiotics during the past 2 months
• Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic.
• Presence of chronic wound infection and osteomyelitis
• Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
• Liver cirrhosis or chronic active hepatitis
• Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone \> 10 mg in the last 3 months
• Anticipated kidney transplant within 9 months
• Expected survival \< 9 months
• Pregnancy, anticipated pregnancy, or breastfeeding
• Incarceration
• Participation in another intervention study
• severe anemia defined as hemoglobin \< 8.0 g/dl any time during the last 2 months

Sponsors & Collaborators

• Dominic Raj: lead

Study Sites (1)

DaVita K Street

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• Amdur RL, Paul R, Barrows ED, Kincaid D, Muralidharan J, Nobakht E, Centron-Vinales P, Siddiqi M, Patel SS, Raj DS. The potassium regulator patiromer affects serum and stool electrolytes in patients receiving hemodialysis. Kidney Int. 2020 Nov;98(5):1331-1340. doi: 10.1016/j.kint.2020.06.042. Epub 2020 Aug 1.

  PMID: 32750456 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperkalemia

Interventions

patiromer

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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: Dominic Raj
• Organization: George Washington Medical Faculty Associates

draj@mfa.gwu.edu

(202) 741-2296

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Division of Renal Disease and Hypertension, Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 31, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 9, 2023
• Results First Posted: March 22, 2023

Record last verified: 2023-04

Locations

US (1)