Phase 2
Completed N=27
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
ESRD · Hyperkalemia · End Stage Renal Disease
Source: ClinicalTrials.gov NCT03326583 ↗
Enrolled (actual)
27
Serious AEs
40.7%
Results posted
Mar 2023
Primary outcomePrimary: 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) — .24; .23; .16; .08 score on a scale — p=.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
.24; .23; .16; .08; .31; .13 | .05 |
| PRIMARY Serum Potassium Level Through 12 Weeks of Treatment |
5.7; 5.1; 5.4 | .05 |
| PRIMARY Changes in Blood Chemistry During the Study |
62.2; 62.6; 59.0; 10.4; 10.6; 10.5 | .05 |
| PRIMARY Stool Electrolytes During the Study Phases |
343; 425; 360; 4132; 5923; 4246 | .05 |
| SECONDARY Changes in Plasma Metabolites Using p-Cresol of Hyperkalemic ESRD Patients Treated With Patiromer |
— | — |
| SECONDARY Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer. |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03326583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.