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

End Stage Renal Disease Clinical Trial

Official title:

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326583
• Other study ID #: 071738
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• ESRD
• Hyperkalemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Patiromer
Patiromer will be orally self-administered by participants.

Locations

Country	Name	City	State
United States	DaVita K Street	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dominic Raj

Country where clinical trial is conducted

United States, 

References & 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Changes in Blood Chemistry During the Study		Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Primary	Stool Electrolytes During the Study Phases		Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Secondary	Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer	Blood and stool samples collected from the ESRD patient will be collected at pre-specified time points and analyzed by untargeted and targeted metabolomics for stool and serum metabolome profiles.	Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Secondary	Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.	Blood and stool samples collected from the ESRD patient will be collected at pre-specified time points and analyzed by metagenomics for gut microbiome profile.	Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)