End Stage Renal Disease, ESRD, Hyperkalemia
Conditions
Keywords
End Stage Renal Disease, ESRD, Hyperkalemia
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.
Interventions
DRUGPatiromer
Patiromer will be orally self-administered by participants.
Sponsors
Dominic Raj
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) | 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 |
| Serum Potassium Level Through 12 Weeks of Treatment | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment) | Blood was collected during Pre-Treatment week 2, Treatment Week 14, and Post-Treatment week 20 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Changes in Gut Microbiome of Hyperkalemic ESRD Patients Treated With Patiromer. | Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patiromer 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. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Patiromer |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 11 |
| Bicarbonate | 20.2 mEq/L STANDARD_DEVIATION 2.9 |
| Blood Urea Nitrogen | 60.9 mg/dl STANDARD_DEVIATION 15.9 |
| Body Mass Index (BMI) | 33 kg/m^2 STANDARD_DEVIATION 7 |
| Calcium | 8.9 mg/dL STANDARD_DEVIATION 0.7 |
| Coronary Artery Disease | 3 Participants |
| Creatinine | 10.2 mg/dl STANDARD_DEVIATION 2 |
| Diabetes | 11 Participants |
| Dialysate calcium | 2.5 mEq/dL STANDARD_DEVIATION 0.1 |
| Dialysate magnesium | 1 mEq/L STANDARD_DEVIATION 0 |
| Dialysate potassium | 2.0 mEq/L STANDARD_DEVIATION 0.2 |
| Dialysate sodium | 136.2 mEq/L STANDARD_DEVIATION 0.9 |
| Doxercalciferol | 3.6 micrograms STANDARD_DEVIATION 2.5 |
| Erythropoietin dose | 6200 UI/mL STANDARD_DEVIATION 2699 |
| Glucose | 120.7 mg/dL STANDARD_DEVIATION 59.6 |
| Heart Failure | 2 Participants |
| Hemoglobin | 10.8 g/dl STANDARD_DEVIATION 1.3 |
| HIV | 5 Participants |
| Kt/V | 1.4 ratio STANDARD_DEVIATION 0.2 |
| Magnesium | 2.6 mg/dL STANDARD_DEVIATION 0.5 |
| Mean Corpuscular Volume (MCV) | 90.8 femtoliters STANDARD_DEVIATION 9.7 |
| Parathyroid hormone (PTH) | 333.7 pg/ml STANDARD_DEVIATION 254.6 |
| Phosphate | 6.0 mg/dL STANDARD_DEVIATION 1.8 |
| Potassium | 5.6 mEq/L STANDARD_DEVIATION 0.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 27 participants |
| Serum Albumin | 4.1 g/dL STANDARD_DEVIATION 0.2 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 13 Participants |
| Sodium | 138.4 mEq/L STANDARD_DEVIATION 3.1 |
| Total Protein | 7.1 g/dL STANDARD_DEVIATION 0.6 |
| Whole Blood Count (WBC) | 6.4 1000 cells/microliters STANDARD_DEVIATION 1.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 11 / 27 |
Outcome results
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
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-Treatment | 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) | Number of stool/days | 1.9 score on a scale |
| Pre-Treatment | 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) | Heartburn | .08 score on a scale |
| Pre-Treatment | 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) | Stool form | 1.43 score on a scale |
| Pre-Treatment | 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) | Acid Reflux | .22 score on a scale |
| Pre-Treatment | 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) | Diarrhea | .17 score on a scale |
| Pre-Treatment | 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) | Hunger Pains | 0 score on a scale |
| Pre-Treatment | 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) | Constipation | .72 score on a scale |
| Pre-Treatment | 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) | Burping | .13 score on a scale |
| Pre-Treatment | 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) | Nausea | .44 score on a scale |
| Pre-Treatment | 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) | Bloated | .14 score on a scale |
| Pre-Treatment | 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) | Rumbling Stomach | .34 score on a scale |
| Pre-Treatment | 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) | Abdomen Pain | .24 score on a scale |
| Pre-Treatment | 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) | Flatus | .53 score on a scale |
| Treatment | 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) | Hunger Pains | .19 score on a scale |
| Treatment | 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) | Heartburn | .31 score on a scale |
| Treatment | 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) | Acid Reflux | .35 score on a scale |
| Treatment | 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) | Nausea | .42 score on a scale |
| Treatment | 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) | Rumbling Stomach | .23 score on a scale |
| Treatment | 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) | Bloated | .12 score on a scale |
| Treatment | 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) | Flatus | .58 score on a scale |
| Treatment | 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) | Stool form | 1.62 score on a scale |
| Treatment | 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) | Number of stool/days | 2.1 score on a scale |
| Treatment | 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) | Abdomen Pain | .23 score on a scale |
| Treatment | 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) | Burping | .08 score on a scale |
| Treatment | 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) | Constipation | .65 score on a scale |
| Treatment | 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) | Diarrhea | .44 score on a scale |
| Post-Treatment | 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) | Hunger Pains | .04 score on a scale |
| Post-Treatment | 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) | Heartburn | .13 score on a scale |
| Post-Treatment | 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) | Burping | .26 score on a scale |
| Post-Treatment | 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) | Flatus | .60 score on a scale |
| Post-Treatment | 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) | Number of stool/days | 2 score on a scale |
| Post-Treatment | 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) | Stool form | 1.41 score on a scale |
| Post-Treatment | 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) | Constipation | .36 score on a scale |
| Post-Treatment | 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) | Acid Reflux | .30 score on a scale |
| Post-Treatment | 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) | Abdomen Pain | .16 score on a scale |
| Post-Treatment | 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) | Diarrhea | .18 score on a scale |
| Post-Treatment | 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) | Rumbling Stomach | .31 score on a scale |
| Post-Treatment | 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) | Nausea | .14 score on a scale |
| Post-Treatment | 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) | Bloated | .14 score on a scale |
p-value: 0.05Fisher Exact
Primary
Changes in Blood Chemistry During the Study
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-Treatment | Changes in Blood Chemistry During the Study | Blood Urea Nitrogen | 62.2 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Creatinine | 10.4 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Potassium | 5.7 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Chloride | 95.2 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Calcium | 8.9 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Phosphate | 6.0 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Magnesium | 2.6 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Sodium | 138.4 mg/dl |
| Pre-Treatment | Changes in Blood Chemistry During the Study | Carbon Dioxide | 20.3 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Chloride | 95.1 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Sodium | 138.5 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Calcium | 9.1 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Phosphate | 6.0 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Magnesium | 2.4 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Blood Urea Nitrogen | 62.6 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Creatinine | 10.6 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Potassium | 5.1 mg/dl |
| Treatment | Changes in Blood Chemistry During the Study | Carbon Dioxide | 20.0 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Magnesium | 2.5 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Creatinine | 10.5 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Blood Urea Nitrogen | 59.0 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Calcium | 8.7 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Chloride | 95.8 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Potassium | 5.4 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Phosphate | 6.3 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Carbon Dioxide | 20.6 mg/dl |
| Post-Treatment | Changes in Blood Chemistry During the Study | Sodium | 139.2 mg/dl |
p-value: 0.05Mixed Models Analysis
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
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-Treatment | Serum Potassium Level Through 12 Weeks of Treatment | 5.7 mEq/L |
| Treatment | Serum Potassium Level Through 12 Weeks of Treatment | 5.1 mEq/L |
| Post-Treatment | Serum Potassium Level Through 12 Weeks of Treatment | 5.4 mEq/L |
p-value: 0.05Mixed Models Analysis
Primary
Stool Electrolytes During the Study Phases
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-Treatment | Stool Electrolytes During the Study Phases | Magnesium | 1923 mcg/g |
| Pre-Treatment | Stool Electrolytes During the Study Phases | Calcium | 7874 mcg/g |
| Pre-Treatment | Stool Electrolytes During the Study Phases | Sodium | 343 mcg/g |
| Pre-Treatment | Stool Electrolytes During the Study Phases | Potassium | 4132 mcg/g |
| Pre-Treatment | Stool Electrolytes During the Study Phases | Phosphate | 7719 mcg/g |
| Treatment | Stool Electrolytes During the Study Phases | Calcium | 13017 mcg/g |
| Treatment | Stool Electrolytes During the Study Phases | Sodium | 425 mcg/g |
| Treatment | Stool Electrolytes During the Study Phases | Potassium | 5923 mcg/g |
| Treatment | Stool Electrolytes During the Study Phases | Magnesium | 1603 mcg/g |
| Treatment | Stool Electrolytes During the Study Phases | Phosphate | 7067 mcg/g |
| Post-Treatment | Stool Electrolytes During the Study Phases | Magnesium | 1665 mcg/g |
| Post-Treatment | Stool Electrolytes During the Study Phases | Calcium | 7635 mcg/g |
| Post-Treatment | Stool Electrolytes During the Study Phases | Sodium | 360 mcg/g |
| Post-Treatment | Stool Electrolytes During the Study Phases | Potassium | 4246 mcg/g |
| Post-Treatment | Stool Electrolytes During the Study Phases | Phosphate | 7670 mcg/g |
p-value: 0.05Mixed Models Analysis
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.
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-treatment)
Population: Targeted metabolomic analyses using p-cresol were not performed due to financial constraints.
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.
Time frame: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Population: Targeted metabolomic analysis using p-cresol were not performed due to financial constraints.