Trial Outcomes & Findings for Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients (NCT NCT03781089)

NCT ID: NCT03781089

Last Updated: 2025-05-30

Results Overview

To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2025-05-30

Participant Flow

Potential participants were identified from a population of individuals who had ESKD and were maintained on thrice-weekly hemodialysis at five outpatient clinics.

A total of 36 individuals with ESKD were enrolled, and prior to randomization three were withdrawn (one due to severe hyperkalemia, one due to prolonged hospitalization, and one due to failure to obtain a baseline electrocardiogram).

Participant milestones

Measure	Patiromer Oral Powder Product Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Overall Study STARTED	17	16
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Patiromer Oral Powder Product Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Overall Study Constipation	1	0
Overall Study Positive pregnancy test	0	1

Baseline Characteristics

Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

Baseline characteristics by cohort

Measure	Patiromer Oral Powder Product n=17 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=16 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Total n=33 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 10.7 • n=5 Participants	58.5 years STANDARD_DEVIATION 11.1 • n=7 Participants	56.2 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.

Outcome measures

Measure	Patiromer Oral Powder Product n=17 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=16 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L	13 episodes	41 episodes

SECONDARY outcome

Timeframe: 4 weeks

To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis.

Outcome measures

Measure	Patiromer Oral Powder Product n=16 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=15 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant	0 episodes per participant Interval 0.0 to 3.0	3 episodes per participant Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Week 3

Population: Not applicable to the Usual Care arm.

Outcome measures

Measure	Patiromer Oral Powder Product n=16 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Median Daily Dose of Patiromer That Was Given in Treatment Arm	8.4 grams/day Standard Deviation 0	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected. Post-dialysis serum potassium concentration was not measured, therefore unable to determine whether post-treatment hyperkalemia occurred.

To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: One participant in Usual Care arm lost the cardiac monitor for week 4.

Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but < 30 seconds), > 3 second pause), atrial fibrillation (> 30 seconds), premature ventricular contractions > 500/24h or bradycardia (heart rate < 40 for 5 consecutive beats).

Outcome measures

Measure	Patiromer Oral Powder Product n=16 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=15 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline Premature ventricular contractions	4 Participants	2 Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline Non-sustained VT events	2 Participants	2 Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline Atrial fibrillation	2 Participants	2 Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline Bradycardia events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4

Population: One participant in Usual Care arm lost the cardiac monitor for week 4.

Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but < 30 seconds), > 3 second pause), atrial fibrillation (> 30 seconds), premature ventricular contractions > 500/24h or bradycardia (heart rate < 40 for 5 consecutive beats).

Outcome measures

Measure	Patiromer Oral Powder Product n=16 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=14 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 Atrial fibrillation	2 Participants	1 Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 Premature ventricular contractions	2 Participants	4 Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 Non-sustained VT events	3 Participants	2 Participants
Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 Bradycardia events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks

To determine feasibility of a large-scale hemodialysis-based trial.

Outcome measures

Measure	Patiromer Oral Powder Product n=17 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=16 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Number of Participants Who Completed All Study Visits	16 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 weeks

PVCs are irregular contractions that start in the ventricles instead of the atria.

Outcome measures

Measure	Patiromer Oral Powder Product n=16 Participants Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=15 Participants Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected due to limited resources.

To determine the between-group differences in serum albumin concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Data not collected due to limited resources.

To determine the between-group differences in PTH concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not collected due to limited resources.

To determine the change in serum potassium concentration two weeks after study drug is discontinued

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not collected due to limited resources.

To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued

Outcome measures

Outcome data not reported

Adverse Events

Patiromer Oral Powder Product

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Usual Care Arm

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patiromer Oral Powder Product n=17 participants at risk Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=16 participants at risk Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Surgical and medical procedures Hospitalization for new vascular access	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Vascular disorders Thrombosis of arteriovenousfistula	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Cardiac disorders Arrhythmia (A-Fib)	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks
Infections and infestations Admitted for dry gangrene and lower extremity wound infection secondary to chronic limb ischemia	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks
Psychiatric disorders Admitted for Altered Mental Status secondary to cefepime neurotoxicity	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks

Other adverse events

Measure	Patiromer Oral Powder Product n=17 participants at risk Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol	Usual Care Arm n=16 participants at risk Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
Nervous system disorders Parasthesias	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Gastrointestinal disorders Constipation	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Skin and subcutaneous tissue disorders Itching	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Surgical and medical procedures Pain from permcath placement	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks
Skin and subcutaneous tissue disorders Skin sensitivity to Holter patch	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks
Gastrointestinal disorders Bloody stools/diarrhea	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Skin and subcutaneous tissue disorders Boil under left arm	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks
Skin and subcutaneous tissue disorders Scabies	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks
Surgical and medical procedures Hospitalization for new vascular access	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Surgical and medical procedures Same day surgery-creation of upper extremity arteriovenous fistula on right arm	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Respiratory, thoracic and mediastinal disorders Emergency Room visit due to shortness of breath	5.9% 1/17 • Up to 6 weeks	0.00% 0/16 • Up to 6 weeks
Surgical and medical procedures Hospitalization for amputation	0.00% 0/17 • Up to 6 weeks	6.2% 1/16 • Up to 6 weeks

Additional Information

Dr. John Middleton

Duke University Medical Center

Phone: 919-684-8111

Email: j.p.middleton@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place