Clinical trial NCT02933450
Conditions: Kidney Failure, Chronic
Sponsor: Baylor College of Medicine
Start date: 2016-08-01; Completion date: 2017-08-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the Investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (K greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.

Detailed description:
This is an open label pilot study. Thirty patients with ESRD who qualify for emergent dialysis on the basis of serum potassium greater than 6mEq/L will be randomly assigned, using a random number generator in blocks of sixes, to standard-of-care (standard care) or patiromer group. Patients in the patiromer group will be given a single dose of 25.2g of patiromer in addition to standard-of-care treatment after randomization. Standard-of-care is defined as intervention or care provided by clinical provider according to individual practice pattern or hospital protocol. Each group of 15 patients will be observed with telemetry monitoring for 10 hours or till hemodialysis units become available for treatment (whichever comes first). Blood draws and electrocardiograms (ECGs) will be performed at enrollment and at 1, 2, 4, 6, 8 and 10hrs thereafter. Serum will be analyzed for basic metabolic panel and magnesium. Medications, including potassium lowering agents, administered during this period will be documented.

1\. Informed consent will be obtained. 2. Subject will be randomized. 3. A. Randomized to Standard of Care (SOC): data will be collected on SOC treatment. 3. B. Randomized to patiromer group: subjects will receive a single dose of 25.2g of patiromer. SOC data will be collected. 4. all subjects will have blood drawn and ECGs (1 12 lead ECG and 1 Lead I Rhythm strip) done at baseline, 1, 2, 4, 6, 8 and 10 hours. Blood will be analyzed for basic metabolic panel and magnesium. 5. CRF completion-SOC data will be recorded in addition to current medications. 6. After subjects have received hemodialysis or reach the 10 hour study period, whichever comes first, the subject will be completed on the study.

Arms: arm 1: Patiromer 25.2 g dose arm 2: Standard of Care
Interventions: intervention 1: Patiromer 25.2 g
Intervention descriptions: intervention 1: Single dose of Patiromer 25.2 g

Protocol documents:
Prot_SAP_000.pdf: 
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