Kidney Failure, Chronic
Conditions
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.
Interventions
DRUGPatiromer 25.2 g
Single dose of Patiromer 25.2 g
Sponsors
Relypsa, Inc.
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Patiromer in Reducing Serum Potassium | 6 hours | serial serum potassium levels will be graphed and compared between the 2 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | 6 hours | adverse events will be recorded and compared between the 2 groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patiromer Group Single dose of Patiromer 25.2 g + Standard of Care | 15 |
| Standard of Care Group Standard of Care | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Patiromer Group | Standard of Care Group | Total |
|---|---|---|---|
| Age, Continuous | 41 years | 48 years | 43 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 4 / 15 | 5 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Efficacy of Patiromer in Reducing Serum Potassium
serial serum potassium levels will be graphed and compared between the 2 groups
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Patiromer | Efficacy of Patiromer in Reducing Serum Potassium | 1 hr | 6.17 mEq/L |
| Patiromer | Efficacy of Patiromer in Reducing Serum Potassium | 2 hr | 5.9 mEq/L |
| Patiromer | Efficacy of Patiromer in Reducing Serum Potassium | 4 hr | 5.73 mEq/L |
| Patiromer | Efficacy of Patiromer in Reducing Serum Potassium | 6 hr | 5.81 mEq/L |
| Standard of Care | Efficacy of Patiromer in Reducing Serum Potassium | 6 hr | 6.27 mEq/L |
| Standard of Care | Efficacy of Patiromer in Reducing Serum Potassium | 1 hr | 6.6 mEq/L |
| Standard of Care | Efficacy of Patiromer in Reducing Serum Potassium | 4 hr | 6.04 mEq/L |
| Standard of Care | Efficacy of Patiromer in Reducing Serum Potassium | 2 hr | 6.47 mEq/L |
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
Time frame: 6 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patiromer | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | Total | 4 Participants |
| Patiromer | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | GI side effects | 1 Participants |
| Patiromer | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | Hypoglycemia | 3 Participants |
| Patiromer | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | Hypomagnesemia | 0 Participants |
| Standard of Care | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | Hypomagnesemia | 0 Participants |
| Standard of Care | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | Total | 5 Participants |
| Standard of Care | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | Hypoglycemia | 3 Participants |
| Standard of Care | Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting. | GI side effects | 2 Participants |