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| Name | Class |
|---|---|
| Relypsa, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patiromer group | Active Comparator | Patiromer 25.2 g dose |
|
| Standard of Care group | No Intervention | Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patiromer 25.2 g | Drug | Single dose of Patiromer 25.2 g |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Patiromer in Reducing Serum Potassium | serial serum potassium levels will be graphed and compared between the 2 groups | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubaid Rafique, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
Data will be coded and shared with the sponsor
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| ID | Title | Description |
|---|---|---|
| FG000 | Patiromer | Single dose of Patiromer 25.2 g + Standard of Care |
| FG001 | Standard of Care | Standard of Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patiromer Group | Single dose of Patiromer 25.2 g + Standard of Care |
| BG001 | Standard of Care Group | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Patiromer in Reducing Serum Potassium | serial serum potassium levels will be graphed and compared between the 2 groups | Posted | Mean | 95% Confidence Interval | mEq/L | 6 hours |
|
|
Adverse events were collected up to 6hrs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patiromer | Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Side Effects | Gastrointestinal disorders | Systematic Assessment | Nausea, vomiting, diarrhea, constipation, abdominal bloating or pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Zubaid Rafiue | Emergency Department, Baylor College of Medicine | 7138732626 | zubaidrafique@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2017 | May 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C568789 | patiromer |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
| 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 | Posted | Count of Participants | Participants | 6 hours |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | Standard of Care | subjects receiving standard of care therapy | 0 | 15 | 0 | 15 | 5 | 15 |
|
| Hypoglycemia | General disorders | Systematic Assessment | Blood sugar < 70 mg/dL |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hypoglycemia |
|
| Hypomagnesemia |
|