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 part 1: screening up to end of treatment (day 28 ±3 days); part 2: day 1 up to end of treatment (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 ~ part 1: screening up to end of treatment (day 28 ±3 days); part 2: day 1 up to end of treatment (up to 52 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 1: screening up to end of treatment (day 28 ±3 days); part 2: day 1 up to end of treatment (up to 52 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: screening up to end of treatment (day 28 ±3 days); part 2: day 1 up to end of treatment (up to 52 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in potassium levels (mmol/L)

Secondary study objectives

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

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