Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia (EMERALD)
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|ClinicalTrials.gov Identifier: NCT03087058|
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : June 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hyperkalemia||Drug: Patiromer||Phase 2|
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|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Cohort 1
Patiromer for age 12 - < 18 years
4.2 g/day, 8.4 g/day and 16.8 g/day
Experimental: Cohort 2
Patiromer for age 6 - < 12 years
2 g/day, 4 g/day and 8 g/day
Experimental: Cohort 3
Patiromer for age 2 - < 6 years
1 g/day, 2 g/day and 4 g/day
- Change in serum potassium (K+) levels from Baseline to Day 14 [ Time Frame: Baseline and Day 14 ]Changes in serum potassium levels will be summarized by starting dose and age group using descriptive statistics. Descriptive statistics include mean, standard deviation, and 95% confidence intervals.
- Proportion of subjects with serum K+ levels in the range of 3.8 - 5.0 mEq/L at Day 14 (Initial PD / Dose Finding Phase) [ Time Frame: Day 14 ]Proportions and associated exact 95% confidence interval will be presented.
- Proportion of subjects with serum K+ levels in the range of 3.8 - 5.0 mEq/L by visit at any time through Month 6 (Long-Term Treatment Phase) [ Time Frame: Up to Month 6 ]Proportions and associated 95% confidence interval will be presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087058
|Contact: EMERALD Clinical Study Team||+41 588 518 000||EMERALD.email@example.com|
|Study Director:||Udo-Michael Göhring||Vifor Pharma, Inc.|