Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia (EMERALD)
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia (EMERALD)
Brief Summary:
The purpose of this study is to evaluate the change in serum (blood) 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).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 54 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: May 1, 2017
Estimated Primary Completion Date: September 2022
Estimated Study Completion Date: September 2022
Arm:
- Experimental: Cohort 1 (Patiromer for age 12 ≤ 18 years)
- Experimental: Cohort 2 (Patiromer for age 6 ≤ 12 years)
- Experimental: Cohort 3 (Patiromer for age 2 ≤ 6 years)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 54 |
| Actual Study start date | 01 May 2017 |
| Estimated Study Completion Date | 01 September 2022 |