Trial Outcomes & Findings for Comparison of Potassium Binders in the ER (NCT NCT04585542)
NCT ID: NCT04585542
Last Updated: 2026-04-22
Results Overview
The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Plasma potassium level measured at 2 and 4 hours after study drug was administered
Results posted on
2026-04-22
Participant Flow
Participant milestones
| Measure |
Polyethylene Glycol 3350 (MiraLax)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
randomized trial
Baseline characteristics by cohort
| Measure |
Polyethylene Glycol 3350 (MiraLax)
n=8 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 Years
STANDARD_DEVIATION 12 • n=60 Participants • randomized trial
|
66 Years
STANDARD_DEVIATION 19 • n=56 Participants • randomized trial
|
56 Years
STANDARD_DEVIATION 21 • n=116 Participants • randomized trial
|
62 Years
STANDARD_DEVIATION 15 • n=7 Participants • randomized trial
|
61 Years
STANDARD_DEVIATION 17 • n=3 Participants • randomized trial
|
|
Sex: Female, Male
Female
|
2 Participants
n=60 Participants • randomized trial
|
3 Participants
n=56 Participants • randomized trial
|
4 Participants
n=116 Participants • randomized trial
|
5 Participants
n=7 Participants • randomized trial
|
14 Participants
n=3 Participants • randomized trial
|
|
Sex: Female, Male
Male
|
6 Participants
n=60 Participants • randomized trial
|
6 Participants
n=56 Participants • randomized trial
|
6 Participants
n=116 Participants • randomized trial
|
5 Participants
n=7 Participants • randomized trial
|
23 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants • randomized trial
|
0 Participants
n=56 Participants • randomized trial
|
0 Participants
n=116 Participants • randomized trial
|
0 Participants
n=7 Participants • randomized trial
|
0 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=60 Participants • randomized trial
|
1 Participants
n=56 Participants • randomized trial
|
0 Participants
n=116 Participants • randomized trial
|
0 Participants
n=7 Participants • randomized trial
|
2 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants • randomized trial
|
0 Participants
n=56 Participants • randomized trial
|
0 Participants
n=116 Participants • randomized trial
|
0 Participants
n=7 Participants • randomized trial
|
0 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=60 Participants • randomized trial
|
0 Participants
n=56 Participants • randomized trial
|
0 Participants
n=116 Participants • randomized trial
|
0 Participants
n=7 Participants • randomized trial
|
0 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
White
|
6 Participants
n=60 Participants • randomized trial
|
8 Participants
n=56 Participants • randomized trial
|
9 Participants
n=116 Participants • randomized trial
|
10 Participants
n=7 Participants • randomized trial
|
33 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants • randomized trial
|
0 Participants
n=56 Participants • randomized trial
|
0 Participants
n=116 Participants • randomized trial
|
0 Participants
n=7 Participants • randomized trial
|
0 Participants
n=3 Participants • randomized trial
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=60 Participants • randomized trial
|
0 Participants
n=56 Participants • randomized trial
|
1 Participants
n=116 Participants • randomized trial
|
0 Participants
n=7 Participants • randomized trial
|
2 Participants
n=3 Participants • randomized trial
|
PRIMARY outcome
Timeframe: Plasma potassium level measured at 2 and 4 hours after study drug was administeredPopulation: Adults with plasma potassium ≥5.5 mEq/L were randomized into the four treatment groups. Temporizing interventions for hyperkalemia management were allowed per discretion of the treating physician.
The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.
Outcome measures
| Measure |
Polyethylene Glycol 3350 (MiraLax)
n=8 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
|---|---|---|---|---|
|
Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered)
4 hours
|
-0.25 mEq/L
Standard Deviation 0.49
|
-0.64 mEq/L
Standard Deviation 0.66
|
-0.60 mEq/L
Standard Deviation 0.72
|
-0.58 mEq/L
Standard Deviation 0.66
|
|
Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered)
2 hours
|
-0.40 mEq/L
Standard Deviation 0.49
|
-0.20 mEq/L
Standard Deviation 0.42
|
-0.65 mEq/L
Standard Deviation 0.89
|
-0.69 mEq/L
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Up to 60 days after study drug was administeredThe investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review.
Outcome measures
| Measure |
Polyethylene Glycol 3350 (MiraLax)
n=5 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
n=6 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
|---|---|---|---|---|
|
Length of ER or Hospital Stay
|
14 days
Interval 4.25 to 19.75
|
4 days
Interval 2.0 to 12.75
|
7 days
Interval 4.0 to 21.5
|
8 days
Interval 3.0 to 37.0
|
SECONDARY outcome
Timeframe: Measured at 4 hours after study drug was administeredThe investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting.
Outcome measures
| Measure |
Polyethylene Glycol 3350 (MiraLax)
n=8 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
|---|---|---|---|---|
|
Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered)
Change in calcium at 4 hours
|
0.15 mg/dL
Standard Deviation 0.23
|
-0.16 mg/dL
Standard Deviation 0.45
|
0.36 mg/dL
Standard Deviation 0.42
|
-0.07 mg/dL
Standard Deviation 0.45
|
|
Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered)
Change in magnesium at 4 hours
|
-0.03 mg/dL
Standard Deviation 0.23
|
0.17 mg/dL
Standard Deviation 0.41
|
0.15 mg/dL
Standard Deviation 0.14
|
-0.08 mg/dL
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 4 hours after study drug was administeredParticipants completed a 1-page brief survey assessing for potential GI side effects with the study drug including bloating, nausea and diarrhea (answers are yes/no).
Outcome measures
| Measure |
Polyethylene Glycol 3350 (MiraLax)
n=7 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
|---|---|---|---|---|
|
Number of Participants Reporting GI Side Effects
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 8 hours of study drug being administeredThe investigators will assess whether dialysis was needed to manage hyperkalemia, within 8 hours of the study drug being given. This will be assessed from medical chart review.
Outcome measures
| Measure |
Polyethylene Glycol 3350 (MiraLax)
n=8 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.
|
Sodium Polystyrene Sulfonate (Kayexalate)
n=9 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Patiromer (Veltassa)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
Sodium Zirconium Cyclosilicate (Lokelma)
n=10 Participants
Participants will be randomized to one of four study arms. They will receive one dose of the study drug.
The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).
|
|---|---|---|---|---|
|
Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Polyethylene Glycol 3350 (MiraLax)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Polystyrene Sulfonate (Kayexalate)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patiromer (Veltassa)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Zirconium Cyclosilicate (Lokelma)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place