NCT03087058

Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia

A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age With Chronic Kidney Disease and Hyperkalemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Vifor Pharma, Inc. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - \< 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much potassium in the blood). Another purpose of the study is to evaluate the safety and tolerability of patiromer in children 2 - \< 18 years of age with CKD and hyperkalemia.

Detailed description

Up to 54 subjects, 2 - \< 18 years of age with CKD (estimated glomerular filtration rate \[eGFR\] \< 90 mL/min/1.73 m2 ) and hyperkalemia (two potassium measurements of 5.1 to \< 6.5 mEq/L performed on separate days) will be enrolled in this open-label, multiple-dose, Phase 2 study. The study will include two treatment phases: Pharmacodynamic (PD; drug effect on potassium) / Dose Finding Phase consisting of the initial 14-day dose finding period followed by an up to 5.5-month Long-Term Treatment Phase for a total study participation duration for individual subjects of up to 6.5 months (includes a 2 week follow up period).

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Patiromer	4.2 g/day, 8.4 g/day and 16.8 g/day
DRUG	Patiromer	2 g/day, 4 g/day and 8 g/day
DRUG	Patiromer	1 g/day, 2 g/day and 4 g/day

Timeline

• Start date: 2017-07-07
• Primary completion: 2021-01-13
• Completion: 2021-04-30
• First posted: 2017-03-22
• Last updated: 2022-10-19
• Results posted: 2022-09-26

Locations

30 sites across 7 countries: United States, Bulgaria, Canada, Georgia, Germany, Poland, Ukraine

Regulatory

• FDA-regulated drug study