Trial Outcomes & Findings for The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (NCT NCT03326583)
NCT ID: NCT03326583
Last Updated: 2023-05-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
Patiromer
This arm is the 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.
Patiromer: Patiromer will be orally self-administered by participants.
|
|---|---|
|
Pre-Treatment
STARTED
|
27
|
|
Pre-Treatment
COMPLETED
|
26
|
|
Pre-Treatment
NOT COMPLETED
|
1
|
|
Treatment
STARTED
|
26
|
|
Treatment
COMPLETED
|
24
|
|
Treatment
NOT COMPLETED
|
2
|
|
Post-Treatment
STARTED
|
24
|
|
Post-Treatment
COMPLETED
|
24
|
|
Post-Treatment
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Baseline characteristics by cohort
| Measure |
Patiromer
n=27 Participants
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.
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
33 kg/m^2
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Diabetes
|
11 Participants
n=5 Participants
|
|
Coronary Artery Disease
|
3 Participants
n=5 Participants
|
|
HIV
|
5 Participants
n=5 Participants
|
|
Heart Failure
|
2 Participants
n=5 Participants
|
|
Hemoglobin
|
10.8 g/dl
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Mean Corpuscular Volume (MCV)
|
90.8 femtoliters
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Whole Blood Count (WBC)
|
6.4 1000 cells/microliters
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Blood Urea Nitrogen
|
60.9 mg/dl
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Creatinine
|
10.2 mg/dl
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sodium
|
138.4 mEq/L
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Potassium
|
5.6 mEq/L
STANDARD_DEVIATION .6 • n=5 Participants
|
|
Bicarbonate
|
20.2 mEq/L
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Calcium
|
8.9 mg/dL
STANDARD_DEVIATION .7 • n=5 Participants
|
|
Phosphate
|
6.0 mg/dL
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Glucose
|
120.7 mg/dL
STANDARD_DEVIATION 59.6 • n=5 Participants
|
|
Parathyroid hormone (PTH)
|
333.7 pg/ml
STANDARD_DEVIATION 254.6 • n=5 Participants
|
|
Magnesium
|
2.6 mg/dL
STANDARD_DEVIATION .5 • n=5 Participants
|
|
Total Protein
|
7.1 g/dL
STANDARD_DEVIATION .6 • n=5 Participants
|
|
Serum Albumin
|
4.1 g/dL
STANDARD_DEVIATION .2 • n=5 Participants
|
|
Kt/V
|
1.4 ratio
STANDARD_DEVIATION .2 • n=5 Participants
|
|
Dialysate potassium
|
2.0 mEq/L
STANDARD_DEVIATION .2 • n=5 Participants
|
|
Dialysate sodium
|
136.2 mEq/L
STANDARD_DEVIATION .9 • n=5 Participants
|
|
Dialysate calcium
|
2.5 mEq/dL
STANDARD_DEVIATION .1 • n=5 Participants
|
|
Erythropoietin dose
|
6200 UI/mL
STANDARD_DEVIATION 2699 • n=5 Participants
|
|
Dialysate magnesium
|
1 mEq/L
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Doxercalciferol
|
3.6 micrograms
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pre-Treatment
n=27 Participants
2 week observation period before treatment
|
Treatment
n=24 Participants
12 week treatment phase, . 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.
Patiromer: Patiromer will be orally self-administered by participants.
|
Post-Treatment
n=24 Participants
6 week follow up, off medication
|
|---|---|---|---|
|
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
Interval 0.14 to 0.75
|
.42 score on a scale
Interval 0.11 to 0.74
|
.14 score on a scale
Interval 0.0 to 0.39
|
|
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
Interval 0.14 to 0.54
|
.23 score on a scale
Interval 0.0 to 0.48
|
.31 score on a scale
Interval 0.0 to 0.62
|
|
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
Interval 0.0 to 0.28
|
.12 score on a scale
Interval 0.0 to 0.24
|
.14 score on a scale
Interval 0.0 to 0.28
|
|
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
Interval 0.02 to 0.25
|
.08 score on a scale
Interval 0.0 to 0.18
|
.26 score on a scale
Interval 0.0 to 0.57
|
|
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
Interval 0.04 to 0.44
|
.23 score on a scale
Interval 0.0 to 0.51
|
.16 score on a scale
Interval 0.0 to 0.32
|
|
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
Interval 0.0 to 0.17
|
.31 score on a scale
Interval 0.02 to 0.59
|
.13 score on a scale
Interval 0.0 to 0.32
|
|
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
Interval 0.03 to 0.41
|
.35 score on a scale
Interval 0.06 to 0.64
|
.30 score on a scale
Interval 0.04 to 0.56
|
|
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
Interval 0.0 to 0.0
|
.19 score on a scale
Interval 0.0 to 0.38
|
.04 score on a scale
Interval 0.0 to 0.13
|
|
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
Interval 0.18 to 0.88
|
.58 score on a scale
Interval 0.21 to 0.94
|
.60 score on a scale
Interval 0.18 to 1.02
|
|
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
Interval 0.31 to 1.12
|
.65 score on a scale
Interval 0.23 to 1.08
|
.36 score on a scale
Interval 0.0 to 0.72
|
|
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
Interval 0.03 to 0.32
|
.44 score on a scale
Interval 0.06 to 0.82
|
.18 score on a scale
Interval 0.02 to 0.34
|
|
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
Interval 1.2 to 1.66
|
1.62 score on a scale
Interval 1.39 to 1.84
|
1.41 score on a scale
Interval 1.14 to 1.68
|
|
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
Interval 1.7 to 2.2
|
2.1 score on a scale
Interval 1.8 to 2.4
|
2 score on a scale
Interval 1.8 to 2.2
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pre-Treatment
n=27 Participants
2 week observation period before treatment
|
Treatment
n=24 Participants
12 week treatment phase, . 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.
Patiromer: Patiromer will be orally self-administered by participants.
|
Post-Treatment
n=24 Participants
6 week follow up, off medication
|
|---|---|---|---|
|
Serum Potassium Level Through 12 Weeks of Treatment
|
5.7 mEq/L
Interval 5.4 to 5.9
|
5.1 mEq/L
Interval 4.9 to 5.2
|
5.4 mEq/L
Interval 5.2 to 5.6
|
PRIMARY outcome
Timeframe: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)Outcome measures
| Measure |
Pre-Treatment
n=27 Participants
2 week observation period before treatment
|
Treatment
n=24 Participants
12 week treatment phase, . 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.
Patiromer: Patiromer will be orally self-administered by participants.
|
Post-Treatment
n=24 Participants
6 week follow up, off medication
|
|---|---|---|---|
|
Changes in Blood Chemistry During the Study
Blood Urea Nitrogen
|
62.2 mg/dl
Interval 56.9 to 67.5
|
62.6 mg/dl
Interval 57.3 to 67.9
|
59.0 mg/dl
Interval 54.1 to 64.0
|
|
Changes in Blood Chemistry During the Study
Creatinine
|
10.4 mg/dl
Interval 9.7 to 11.0
|
10.6 mg/dl
Interval 9.9 to 11.4
|
10.5 mg/dl
Interval 9.9 to 11.1
|
|
Changes in Blood Chemistry During the Study
Sodium
|
138.4 mg/dl
Interval 137.3 to 139.5
|
138.5 mg/dl
Interval 137.5 to 139.6
|
139.2 mg/dl
Interval 135.7 to 142.6
|
|
Changes in Blood Chemistry During the Study
Potassium
|
5.7 mg/dl
Interval 5.4 to 5.9
|
5.1 mg/dl
Interval 4.9 to 5.2
|
5.4 mg/dl
Interval 5.2 to 5.6
|
|
Changes in Blood Chemistry During the Study
Chloride
|
95.2 mg/dl
Interval 94.0 to 96.5
|
95.1 mg/dl
Interval 94.0 to 96.3
|
95.8 mg/dl
Interval 94.6 to 97.0
|
|
Changes in Blood Chemistry During the Study
Carbon Dioxide
|
20.3 mg/dl
Interval 19.4 to 21.2
|
20.0 mg/dl
Interval 19.1 to 20.9
|
20.6 mg/dl
Interval 19.5 to 21.7
|
|
Changes in Blood Chemistry During the Study
Calcium
|
8.9 mg/dl
Interval 8.7 to 9.1
|
9.1 mg/dl
Interval 8.9 to 9.4
|
8.7 mg/dl
Interval 8.5 to 8.9
|
|
Changes in Blood Chemistry During the Study
Phosphate
|
6.0 mg/dl
Interval 5.3 to 6.7
|
6.0 mg/dl
Interval 5.4 to 6.7
|
6.3 mg/dl
Interval 5.7 to 7.0
|
|
Changes in Blood Chemistry During the Study
Magnesium
|
2.6 mg/dl
Interval 2.4 to 2.8
|
2.4 mg/dl
Interval 2.3 to 2.6
|
2.5 mg/dl
Interval 2.4 to 2.7
|
PRIMARY outcome
Timeframe: Wk 2 (Pre-Treatment), Wk 14 (Treatment), Wk 20 (Post-Treatment)Outcome measures
| Measure |
Pre-Treatment
n=27 Participants
2 week observation period before treatment
|
Treatment
n=24 Participants
12 week treatment phase, . 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.
Patiromer: Patiromer will be orally self-administered by participants.
|
Post-Treatment
n=24 Participants
6 week follow up, off medication
|
|---|---|---|---|
|
Stool Electrolytes During the Study Phases
Magnesium
|
1923 mcg/g
Interval 1380.0 to 2466.0
|
1603 mcg/g
Interval 1347.0 to 1860.0
|
1665 mcg/g
Interval 1372.0 to 1958.0
|
|
Stool Electrolytes During the Study Phases
Sodium
|
343 mcg/g
Interval 222.0 to 464.0
|
425 mcg/g
Interval 288.0 to 562.0
|
360 mcg/g
Interval 241.0 to 479.0
|
|
Stool Electrolytes During the Study Phases
Potassium
|
4132 mcg/g
Interval 3627.0 to 4637.0
|
5923 mcg/g
Interval 4796.0 to 7050.0
|
4246 mcg/g
Interval 3858.0 to 4634.0
|
|
Stool Electrolytes During the Study Phases
Calcium
|
7874 mcg/g
Interval 5799.0 to 9948.0
|
13017 mcg/g
Interval 10448.0 to 15586.0
|
7635 mcg/g
Interval 5568.0 to 9703.0
|
|
Stool Electrolytes During the Study Phases
Phosphate
|
7719 mcg/g
Interval 6630.0 to 8809.0
|
7067 mcg/g
Interval 5780.0 to 8354.0
|
7670 mcg/g
Interval 6341.0 to 8998.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Patiromer
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patiromer
n=27 participants at risk
This arm is the 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.
|
|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Cardiac disorders
Hypertension
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Infections and infestations
Fever
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Metabolism and nutrition disorders
Hypoglcymia
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Infections and infestations
MRSA Infection
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Infections and infestations
Infection
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
General disorders
Dizzy and Disoriented
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Gastrointestinal disorders
Nasuea
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Skin and subcutaneous tissue disorders
Right Arm Collulitis
|
3.7%
1/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
Other adverse events
| Measure |
Patiromer
n=27 participants at risk
This arm is the 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.
|
|---|---|
|
Metabolism and nutrition disorders
hypomagnesemia
|
0.00%
0/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/27 • The study period during which adverse events must be reported is defined as the period from initiation of the study procedures to the end of the treatment follow-up. In other words, AE documentation should begin when the patient signs the informed consent form. Encourage participants to contact the investigator after the conclusion of the trial if subsequent medical events occur which the participant, or the participant's physician, believes may be related to participation in the research study
The center staff will collect adverse event data at each study visit by checking several different sources of information by asking participants directly, evaluating medical record information, reviewing all laboratory values, examining reports generated by the data management system based on data entered into logs and forms. AE information may also be reported between scheduled study visits via regular contacts if the participant reports health related problems or concerns
|
Additional Information
Dominic Raj
George Washington Medical Faculty Associates
Phone: (202) 741-2296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place