Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Sponsor: Baylor College of Medicine

Relypsa For ED Acute Hyperkalemia Control and Reduction 
(REDUCE) 
 
 
 
 
 
 
 
 
NCT 02933450 
June 21st 2017 
 
 

Protocol and Statistical Analysis 
 
Study design and setting:  This is a single center, single blinded, open label, feasibility pilot study 
performed at a large inner-city academic ED. The study was approved by the institutional review board. 
Selection of participants: Patients ≥18 years of age and ESRD, who had serum potassium ≥ 6.0mEq/L, 
were eligible for enrollment.  Exclusions were: i) a significant arrhythmia on initial EKG (determined by 
clinical provider), ii) known allergy to patiromer, iii) an oral potassium binder administered prior to 
enrollment, iv) pregnancy, v) not anticipated to need medical management of hyperkalemia for at least 
4 hours (i.e. hemodialysis unit and staff available for emergent dialysis and medical management is not 
necessary). 
Interventions:  After obtaining informed consent, patients were randomly assigned to standard-of-care 
(SOC) or a single dose of 25.2g oral patiromer plus SOC (PAT) cohort.  Standard-of-care is defined as 
intervention provided by clinical provider according to individual practice pattern or hospital protocol.  
Providers were blinded to treatment assignment and all data gathered by the research team.  Patients 
were observed with telemetry monitoring for up to 10 hours or until they received hemodialysis, 
whichever occurred first.  Blood draws and electrocardiograms (ECGs) were performed at enrollment 
and at 1, 2, 4, 6 and 8hrs hours thereafter. 
Outcomes:  The primary outcome was the difference in serum potassium between SOC and PAT groups 
at 2, 4, and 6 hours.  Recorded adverse events included rates of new gastrointestinal symptoms, 
hypomagnesemia, and hypoglycemia. 
Analysis:  Demographic characteristics were analyzed with Wilcoxon rank sum and Chi-squared test.  
Baseline serum potassium was compared using median and inter-quartile range (IQR). A mixed-effect 
linear regression model with an unstructured covariance structure was used to model potassium levels 
by adjusting for time, group interaction, and baseline potassium. The adjusted means of potassium 
levels over time were computed for each group. Contrasts between the two groups at each time point 
were evaluated and adjustment of multiple comparisons was made using Bonferroni's method. The 
amount of insulin and albuterol given and the number of interventions within 2, 4, and 6 hours were 
compared using the Wilcoxon rank sum test. 
Adverse events were reported and analyzed using Fischer’s exact test or Chi squared test.  Analyses 
were conducted per protocol basis; patients who went for hemodialysis treatment before 4hrs of 
medical treatment were excluded from the analysis