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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: Up to 54 subjects, 2 - < 18 years of age with CKD (estimated glomerular filtration rate [eGFR] < 60 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).
Sponsor: Relypsa, Inc.

Current Primary Outcome: Change in serum potassium 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Relypsa, Inc.

Dates:
Date Received: March 16, 2017
Date Started: April 2017
Date Completion: August 2020
Last Updated: March 16, 2017
Last Verified: March 2017