Kidney Failure, Chronic Clinical Trial
Official title:
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
NCT number | NCT02933450 |
Other study ID # | H-39340 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | August 2017 |
Verified date | May 2019 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ESRD patients with serum potassium greater than or equal to 6.0 mEq/L - Emergent dialysis not expected to be available for 6 hours Exclusion Criteria: - new clinically significant arrhythmia on initial ECG - patiromer is contraindicated - have received SPS |
Country | Name | City | State |
---|---|---|---|
United States | Ben Taub Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Relypsa, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Patiromer in Reducing Serum Potassium | serial serum potassium levels will be graphed and compared between the 2 groups | 6 hours | |
Secondary | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | adverse events will be recorded and compared between the 2 groups | 6 hours |
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