drugset / Trial / NCT03087058
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2017-07-07
- Primary completion
- 2021-01-13
- Completion
- 2021-04-30
Outcome
Outcome not reported
Stopped: “The study was terminated on 13 May 2022 due to a modification to the PIP/PSP”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Patiromer | Other / unclassified | 1 g | Oral |
| Subject | Patiromer | Other / unclassified | 2 g | Oral |
| Subject | Patiromer | Other / unclassified | 4 g | Oral |
| Subject | Patiromer | Other / unclassified | 4.2 g | Oral |
| Subject | Patiromer | Other / unclassified | 8 g | Oral |
| Subject | Patiromer | Other / unclassified | 8.4 g | Oral |
| Subject | Patiromer | Other / unclassified | 16.8 g | Oral |
Indications
No indication recorded.