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Potassium Binder

Patiromer for Hyperkalemia

Phase 2
Waitlist Available
Research Sponsored by Dominic Raj
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects on stable hemodialysis for more than 90 days.
Age 18-85 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up wk 2 (pre-treatment), wk 14 (treatment), wk 20 (post-treatment)
Awards & highlights

Study 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.

Eligible Conditions
  • Hyperkalemia
  • Kidney Failure
  • Renal Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~wk 2 (pre-treatment), wk 14 (treatment), wk 20 (post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and wk 2 (pre-treatment), wk 14 (treatment), wk 20 (post-treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Changes in Blood Chemistry During the Study
Serum Potassium Level Through 12 Weeks of Treatment
+1 more
Secondary outcome measures
Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer.
Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer

Trial Design

1Treatment groups
Experimental Treatment
Group I: PatiromerExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patiromer
FDA approved

Find a Location

Who is running the clinical trial?

Dominic RajLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Dominic Raj 2017. "The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03326583.
~4 spots leftby Apr 2025
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