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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
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The purpose of this study is to determine whether once-daily dosing of patiromer will reduce the frequency of hyperkalemic episodes in ESRD (end stage renal disease) study participants who receive conventional hemodialysis (HD). The study objective is to determine if patiromer administered orally once a day with breakfast or lunch will reduce episodes of hyperkalemia in ESRD study participants who receive thrice-weekly HD.
This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 study participants (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.
This is a proof of concept study, to determine whether administration of patiromer has the potential to change the risk category for ESRD patients who are on conventional HD schedules. In addition, the study will develop and pilot study procedures that could be implemented in a large-scale clinical trial. By nature of the limited size of the study, the power of the trial will be limited. Reducing serum potassium with the use of low dialysate potassium is actually associated with an increased risk of sudden cardiac death. Furthermore, HD patients already carry a high pill burden, and it is unclear if prescription of an additional oral medication will reduce the frequency of episodic hyperkalemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patiromer Oral Powder Product | Experimental | Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. |
|
| Usual care arm | No Intervention | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patiromer Oral Powder Product | Drug | Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L | To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant | To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis. | 4 weeks |
| Median Daily Dose of Patiromer That Was Given in Treatment Arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Middleton, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Dialysis Sites | Durham | North Carolina | 27713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32588430 | Derived | Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2. |
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Participant level data will not be shared.
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A total of 36 individuals with ESKD were enrolled, and prior to randomization three were withdrawn (one due to severe hyperkalemia, one due to prolonged hospitalization, and one due to failure to obtain a baseline electrocardiogram).
Potential participants were identified from a population of individuals who had ESKD and were maintained on thrice-weekly hemodialysis at five outpatient clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patiromer Oral Powder Product | Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| FG001 | Usual Care Arm | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patiromer Oral Powder Product | Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Number of Episodes of Serum Potassium ≥ 5.5 mEq/L | To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis. | Posted | Number | episodes | Week 4 |
|
Up to 6 weeks
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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 Oral Powder Product | Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for new vascular access | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Parasthesias | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Middleton | Duke University Medical Center | 919-684-8111 | j.p.middleton@duke.edu |
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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 | May 17, 2019 | Mar 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
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This is a prospective, randomized, open-label trial. Eligible ESRD patients who are on thrice weekly HD schedule will be screened from retrospective review of clinical and laboratory parameters from our clinical practice group. A total of 40 patients (randomized 1:1 study drug: usual care) will be enrolled. Duration of study medication exposure will be 4 weeks. The total duration of study, from enrollment until the end of the washout period will be 7 weeks.
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The study is open-label and therefore the subjects, coordinators and investigators are not blinded to the intervention. Titration of the patiromer will require viewing of the serum potassium values. During the data analysis, however, personnel involved will remain blinded.
|
|
| Week 3 |
| Number of Additional Hemodialysis Treatments Due to Hyperkalemia | To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia | 4 weeks |
| Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline | Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but < 30 seconds), > 3 second pause), atrial fibrillation (> 30 seconds), premature ventricular contractions > 500/24h or bradycardia (heart rate < 40 for 5 consecutive beats). | Baseline |
| Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 | Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but < 30 seconds), > 3 second pause), atrial fibrillation (> 30 seconds), premature ventricular contractions > 500/24h or bradycardia (heart rate < 40 for 5 consecutive beats). | Week 4 |
| Number of Participants Who Completed All Study Visits | To determine feasibility of a large-scale hemodialysis-based trial. | 4 weeks |
| Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours | PVCs are irregular contractions that start in the ventricles instead of the atria. | 4 weeks |
| Change in Serum Albumin Concentration | To determine the between-group differences in serum albumin concentrations. | 4 weeks |
| Change in Parathyroid Hormone (PTH) Concentration | To determine the between-group differences in PTH concentrations. | 4 weeks |
| Change in Serum Potassium Concentration Two Weeks After Study Drug is Discontinued | To determine the change in serum potassium concentration two weeks after study drug is discontinued | 6 weeks |
| Change in Serum Phosphorus Concentration Two Weeks After Study Drug Has Been Discontinued | To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued | 6 weeks |
| BG001 | Usual Care Arm | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care Arm | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol |
|
|
|
| Secondary | Number of Episodes of Serum Potassium ≥ 5.5 mEq/L Per Participant | To determine if patiromer administered orally once a day with the mid-day meal will reduce episodes of hyperkalemia in ESRD patients who receive thrice-weekly HemoDiaylsis. | Posted | Median | Full Range | episodes per participant | 4 weeks |
|
|
|
|
| Secondary | Median Daily Dose of Patiromer That Was Given in Treatment Arm | Not applicable to the Usual Care arm. | Posted | Median | Standard Deviation | grams/day | Week 3 |
|
|
|
| Secondary | Number of Additional Hemodialysis Treatments Due to Hyperkalemia | To determine the between-group differences in need for additional hemodialysis treatments due to hyperkalemia | Data not collected. Post-dialysis serum potassium concentration was not measured, therefore unable to determine whether post-treatment hyperkalemia occurred. | Posted | 4 weeks |
|
|
| Secondary | Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Baseline | Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but < 30 seconds), > 3 second pause), atrial fibrillation (> 30 seconds), premature ventricular contractions > 500/24h or bradycardia (heart rate < 40 for 5 consecutive beats). | One participant in Usual Care arm lost the cardiac monitor for week 4. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants With Significant Arrhythmia Events as Detected With Cardiac Monitors at Week 4 | Clinically significant cardiac arrhythmias included sustained ventricular tachycardia (VT), ventricular fibrillation, asystolic cardiac arrest, non-sustained VT (≥ 3 beats but < 30 seconds), > 3 second pause), atrial fibrillation (> 30 seconds), premature ventricular contractions > 500/24h or bradycardia (heart rate < 40 for 5 consecutive beats). | One participant in Usual Care arm lost the cardiac monitor for week 4. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Number of Participants Who Completed All Study Visits | To determine feasibility of a large-scale hemodialysis-based trial. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Number of Participants With More Than 1000 Premature Ventricular Contractions (PVCs) in 24 Hours | PVCs are irregular contractions that start in the ventricles instead of the atria. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Change in Serum Albumin Concentration | To determine the between-group differences in serum albumin concentrations. | Data not collected due to limited resources. | Posted | 4 weeks |
|
|
| Secondary | Change in Parathyroid Hormone (PTH) Concentration | To determine the between-group differences in PTH concentrations. | Data not collected due to limited resources. | Posted | 4 weeks |
|
|
| Secondary | Change in Serum Potassium Concentration Two Weeks After Study Drug is Discontinued | To determine the change in serum potassium concentration two weeks after study drug is discontinued | Data not collected due to limited resources. | Posted | 6 weeks |
|
|
| Secondary | Change in Serum Phosphorus Concentration Two Weeks After Study Drug Has Been Discontinued | To determine the change in serum phosphorus concentration two weeks after study drug has been discontinued | Data not collected due to limited resources. | Posted | 6 weeks |
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| 5 |
| 17 |
| EG001 | Usual Care Arm | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol | 0 | 16 | 2 | 16 | 5 | 16 |
| Thrombosis of arteriovenousfistula | Vascular disorders | Non-systematic Assessment |
|
| Arrhythmia (A-Fib) | Cardiac disorders | Non-systematic Assessment |
|
| Admitted for dry gangrene and lower extremity wound infection secondary to chronic limb ischemia | Infections and infestations | Non-systematic Assessment |
|
| Admitted for Altered Mental Status secondary to cefepime neurotoxicity | Psychiatric disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain from permcath placement | Surgical and medical procedures | Non-systematic Assessment |
|
| Skin sensitivity to Holter patch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bloody stools/diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Boil under left arm | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Scabies | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hospitalization for new vascular access | Surgical and medical procedures | Non-systematic Assessment |
|
| Same day surgery-creation of upper extremity arteriovenous fistula on right arm | Surgical and medical procedures | Non-systematic Assessment |
|
| Emergency Room visit due to shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization for amputation | Surgical and medical procedures | Non-systematic Assessment |
|
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| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
| Atrial fibrillation |
|
| Bradycardia events |
|
| Atrial fibrillation |
|
| Bradycardia events |
|