Your session is about to expire
← Back to Search
Cation Exchange Resin
Potassium Binders for Hyperkalemia (KBindER Trial)
Phase 4
Recruiting
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up plasma potassium level measured at 2 and 4 hours after study drug was administered
Awards & highlights
KBindER Trial Summary
This trial compares the effectiveness of three different oral potassium binders at lowering blood potassium in patients who come to the emergency room with acute hyperkalemia.
Who is the study for?
This trial is for adults over 18 with high blood potassium levels (above 5.5 mEq/L) who can consent to participate. It's not for those with recent bowel surgery, blockages, certain blood issues mimicking high potassium, pregnant women, people with active psychiatric disorders or severe allergies to the drugs being tested.Check my eligibility
What is being tested?
The study compares three oral medications—Polyethylene Glycol 3350, Sodium Polystyrene Sulfonate [SPS], and Patiromer—to see which is best at lowering dangerously high potassium in hospital patients.See study design
What are the potential side effects?
Possible side effects of these potassium binders include digestive discomfort like nausea or constipation, electrolyte imbalances that could affect heart rhythm and muscle function, and rarely intestinal damage.
KBindER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
KBindER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 2 and 4 hours after study drug was administered
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 2 and 4 hours after study drug was administered
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in blood potassium level
Secondary outcome measures
Change in calcium, phosphorus and magnesium
Dialysis yes/no within 8 hours
Length of ER or hospital stay
+1 moreKBindER Trial Design
4Treatment groups
Experimental Treatment
Group I: Sodium zirconium cyclosilicate (Lokelma)Experimental Treatment1 Intervention
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).
Group II: Sodium polystyrene sulfonate (Kayexalate)Experimental Treatment1 Intervention
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).
Group III: Polyethylene glycol 3350 (MiraLax)Experimental Treatment1 Intervention
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.
Group IV: Patiromer (Veltassa)Experimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene glycol
FDA approved
Patiromer
FDA approved
Sodium zirconium cyclosilicate
FDA approved
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,922,923 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetic ketoacidosis or high potassium levels due to a condition that can be treated directly.I am currently experiencing a psychiatric disorder.Your blood potassium level is higher than 5.5 mEq/L.My high potassium levels are due to factors like tight fist clenching or a bad blood sample.I am not taking sorbitol with sodium polystyrene sulfonate.I have a blockage in my intestines.You have had a bad reaction to sodium polystyrene sulfonate resin or patiromer in the past.I am 18 years old or older.I have had recent surgery on my intestines.I am scheduled for a dialysis session within 4 hours after joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Patiromer (Veltassa)
- Group 2: Sodium zirconium cyclosilicate (Lokelma)
- Group 3: Polyethylene glycol 3350 (MiraLax)
- Group 4: Sodium polystyrene sulfonate (Kayexalate)
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are part of this clinical trial?
"Yes, this is an ongoing study that is looking for new participants. The trial was first posted on October 20th, 2020, and the most recent update was on August 6th, 2021. They are recruiting for a total of 120 patients at 1 medical site."
Answered by AI
Why is Polyethylene Glycol 3350 commonly ingested?
"Polyethylene Glycol 3350 is an effective medical solution for patients struggling with colonoscopy, bowel preparation therapy, and dry eyes."
Answered by AI
Are there any other instances where Polyethylene Glycol 3350 has been studied?
"As of right now, there are 29 ongoing clinical trials for Polyethylene Glycol 3350. Out of those 29 trials, 7 are in Phase 3. Most of the trials taking place for Polyethylene Glycol 3350 are based in Durham, North carolina, but 853 locations worldwide are running trials for Polyethylene Glycol 3350."
Answered by AI
What is the maximum amount of Polyethylene Glycol 3350 that a person can consume without experiencing negative health effects?
"Polyethylene Glycol 3350 is a safe treatment option, as it has been approved in Phase 4 of clinical trials."
Answered by AI
Are there any more positions open for this research project?
"Yes, this is an ongoing study that was originally posted on October 20th, 2020. The most recent update was on August 6th, 2021."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger