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Potassium Binder
Patiromer for Pediatric Hyperkalemia
Phase 2
Recruiting
Research Sponsored by Vifor Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to day 3, day 7, day 14, day 28, and during part 2: up to 52 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a medication to safely lower high potassium levels in children under 6.
Who is the study for?
This trial is for children under 6 with hyperkalemia, a condition of high potassium levels in the blood. They must be on stable doses of certain medications if used and able to take food and medicine regularly, including through feeding tubes. Infants born preterm or those with severe kidney issues, hypersensitivity to patiromer, active cancer, significant GI conditions affecting drug transit, or recent investigational drug use are excluded.
What is being tested?
The study tests the effects and safety of patiromer in treating hyperkalemia in young children. It aims to understand how well the drug works (pharmacodynamics), its tolerability, and any side effects it may cause during treatment.
What are the potential side effects?
While specific side effects for this age group aren't detailed here, patiromer can generally cause digestive issues like constipation or diarrhea in adults. Children might experience similar side effects; monitoring by healthcare providers will be essential.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to day 3, day 7, day 14, day 28, and during part 2: up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to day 3, day 7, day 14, day 28, and during part 2: up to 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in potassium levels (mmol/L)
Occurrence of abnormal clinical laboratory value findings
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PatiromerExperimental Treatment1 Intervention
4-week pharmacodynamic (PD)/dose-ranging period
Cohort 1: 6 to \<12 years of age
Cohort 2: 2 to \<6 years of age
Cohort 3: 0 to \<2 years of age); In Cohort 3, a minimum of 3 study participants will be assessed in the sub-group of 0 to \<6 months and another 3 study participants in the sub-group 6 to \<24 months of age.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patiromer
2013
Completed Phase 4
~1780
Find a Location
Who is running the clinical trial?
Vifor Pharma, Inc.Lead Sponsor
5 Previous Clinical Trials
1,605 Total Patients Enrolled
3 Trials studying Hyperkalemia
1,268 Patients Enrolled for Hyperkalemia
Julian Platon, MD, PhDStudy DirectorVifor Pharma, Inc.
2 Previous Clinical Trials
223 Total Patients Enrolled
2 Trials studying Hyperkalemia
223 Patients Enrolled for Hyperkalemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was not born before 37 weeks of pregnancy.I have kidney issues like dialysis, narrowed arteries, recent injury, or past insufficiency but not chronic disease.I cannot have blood drawn due to my condition, like anemia or low body weight.I am under 12 years old and will not turn 12 during the first 28 days of the trial.My child is under 12 and has high potassium levels.I am currently being treated for cancer or had cancer within the last 2 years.My child is under 2 and had a sibling who died suddenly in infancy.I am on immunosuppressive therapy due to an organ transplant or will have a kidney transplant within 28 days.I am not pregnant, not breastfeeding, and have been using birth control for at least 1 month.I do not have severe GI issues that could affect medication absorption.My medication doses have been stable for at least 14 days and won't change soon.I have been on a stable dose of my blood pressure or heart medication for at least 14 days.I can be fed and take medication through a tube if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Patiromer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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