Not provided
Not provided
Not provided
Not provided
The study was stopped due to a higher than expected screen fail rate (83%) which lead to very low patient enrollment into the study. It should be noted that the decision to terminate the study is not related to safety concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD
NEUTRALIZE is a prospective, randomized, double-blind, placebo-controlled, parallel, multicenter, Phase IIIb study to investigate the safety and efficacy of SZC in patients with hyperkalemia and low bicarbonate (metabolic acidosis ).
The study will be conducted in the United States (US) at approximately 35 investigative sites.
After screening on Day 1, all eligible patients will receive open-label SZC for up to 48 hours. Patients who achieve normokalemia within 48 hours will be randomized 1:1 into the double-blind randomized treatment phase to receive SZC or placebo. Study treatment will end with the Day 29 visit, which will be followed by a follow-up visit 7 days after the last administration of study medication.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label correction phase (up to 48 hours) | Experimental | All eligible patients will receive SZC 10 g TID for up to 48 hours. Patients with POCT (Point-of-Care-Test) K+ ≥5.1 mmol/L after 24 hours will continue on SZC 10 g TID for another 24 hours. Patients who achieve normokalemia (defined as POCT K+ between 3.5 and 5.0 mmol/L inclusive) after receiving SZC 10 g TID for up to 48 hours will proceed to randomization. Patients with POCT K+ <3.5mmol/L at any time during the open-label phase will be withdrawn from study treatment and will be followed per protocol. |
|
| Randomized, placebo controlled phase (Day 2 or 3 to Day 29) | Experimental | Patients will be randomized to SZC 10 g QD or placebo 10 g QD. The dose of SZC/placebo will be titrated by increasing or decreasing the dose by 5 g increments at 1-week intervals to between 5 g every other day (QOD) and 15 g QD of the randomized phase to maintain normokalemia by POCT K+. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium zirconium cyclosilicate | Drug | Investigational medicinal product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Response was defined as a subject having serum potassium (sK+) within 3.5-5.0 mmol/L at the EOT visit, and no use of rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period. Participants who used rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period were assigned a non-response. Participants who died prior to the EOT visit were treated as non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. | Day 1 of randomization phase to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Bicarbonate at Day 29 | Least-squares mean calculated with a repeated measures analysis of covariance model where the dependent variable was post randomization serum bicarbonate and with fixed terms for randomized treatment group and serum bicarbonate. | Day 29 |
| Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Florence | Alabama | 35630 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38622759 | Derived | Ash SR, Batlle D, Kendrick J, Oluwatosin Y, Kooienga L, Eudicone JM, Sundin AK, Guerrieri E, Fried LF. Sodium Zirconium Cyclosilicate in CKD, Hyperkalemia, and Metabolic Acidosis: NEUTRALIZE Randomized Study. Kidney360. 2024 Jun 1;5(6):812-820. doi: 10.34067/KID.0000000000000446. Epub 2024 Apr 16. |
| Label | URL |
|---|---|
| CSRsynopsis\_redacted | View source |
Not provided
One participants was randomized to the double-blind treatment phase in error but did not receive treatment. This participant is noted as not completing the open-label phase in the table below.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Zirconium Cyclosilicate (SZC) | Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours (not applicable in the open-label phase) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Open-label Period |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2022 | Jun 13, 2023 |
Not provided
Not provided
NEUTRALIZE is a prospective, randomized, double-blind, placebo-controlled, parallel, multicenter, Phase IIIb study
Not provided
Not provided
Not provided
|
| Placebo | Drug | Plabeco comparator |
|
Occurrence (yes/no) of participants having an increase in serum bicarbonate of greater than or equal to 3 mmol/L from baseline (Day 1) to EOT (Day 29) without need for rescue treatment for metabolic acidosis (low bicarbonate). Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. |
| Day 1 to Day 29 of randomization phase |
| Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L | Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who had used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who died prior to the EOT visit were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. | Day 1 to Day 29 of randomization phase |
| Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 2 mmol/L at the EOT visit and no use of rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Day 1 to Day 29 of randomization phase |
| Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia | Participants with normal sK+ between 3.5 and 5.0 mmol/L inclusive at EOT and increase in serum bicarbonate greater than or equal to 3 mmol/L from Day 1 without rescue treatment for metabolic acidosis (low bicarbonate) or hyperkalemia. Response was a participant with sK+ within 3.5-5.0 mmol/L and increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit and no use of rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate or HK during the randomized placebo-controlled period had last observation prior to rescue therapy carried forward. Participants lost to follow-up prior to EOT visit had response as missing. Logistic regression model included response status (response/non-response) as dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Day 1 to Day 29 of randomization phase |
| Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate) | Response was defined as a participant with sK+ within 3.5-5.0 mmol/L and serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for hyperkalaemia or low bicarbonate. Participants who used rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Day 1 to Day 29 of randomization phase |
| Occurrence (Yes/no) of Participants Needing Rescue Treatment for Low Sodium Bicarbonate | Occurrence (yes/no) of participants needing rescue treatment for low sodium bicarbonate any time during the randomized phase | Day 1 to Day 29 of randomization phase |
| Chula Vista |
| California |
| 91910 |
| United States |
| Research Site | Downey | California | 90242 | United States |
| Research Site | El Centro | California | 92243 | United States |
| Research Site | South Gate | California | 90280 | United States |
| Research Site | Victorville | California | 92395 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Denver | Colorado | 80230 | United States |
| Research Site | Coral Gables | Florida | 33134 | United States |
| Research Site | Columbus | Georgia | 31904 | United States |
| Research Site | Hinsdale | Illinois | 60521 | United States |
| Research Site | Kansas City | Missouri | 64111 | United States |
| Research Site | Las Vegas | Nevada | 89128 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Site | New Bern | North Carolina | 28562 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Providence | Rhode Island | 02903 | United States |
| Research Site | Spartanburg | South Carolina | 29306 | United States |
| Research Site | Chattanooga | Tennessee | 37404 | United States |
| Research Site | Memphis | Tennessee | 38163 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | San Antonio | Texas | 78258 | United States |
| Research Site | Shenandoah | Texas | 77384 | United States |
| Research Site | Alexandria | Virginia | 22304 | United States |
| Research Site | Norfolk | Virginia | 23510 | United States |
| Research Site | Bellevue | Washington | 98004 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | San Juan | 00918 | Puerto Rico |
| SAP\_redacted | View source |
| CSP\_redacted | View source |
| FG001 | Placebo | Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). Double-blind treatment phase: Double-blind placebo for up to 48 hours (not applicable in the open-label phase) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Treatment Phase |
|
|
Full analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Zirconium Cyclosilicate (SZC) | Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours |
| BG001 | Placebo | Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). Double-blind treatment phase: Double-blind placebo for up to 48 hours |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Age at Screening | Full Analysis Set | Number | Participants |
| ||||||||||||||
| Sex: Female, Male | Full Analysis Set | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Full Analysis Set | Number | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Full Analysis Set | Number | Participants |
| |||||||||||||||
| Diabetes status | Count of Participants | Participants |
| ||||||||||||||||
| Chronic Kidney Disease (CKD) Status | Stage 3a (G3a) - an eGFR of 45 to 59ml/min; Stage 3b (G3b) - an eGFR of 30 to 44ml/min; Stage 4 (G4) - an eGFR of 15 to 29ml/min; Stage 5 (G5) - an eGFR below 15ml/min, meaning the kidneys have lost almost all of their function | Count of Participants | Participants |
| |||||||||||||||
| Chronic Heart Failure Status | Count of Participants | Participants |
|
| 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 | Occurrence (Yes/no) of Participants Having Normal Serum Potassium (sK+) Between 3.5 and 5.0 mmol/L Inclusive at End of Treatment (EOT) Without Need for Rescue Treatment for Hyperkalemia at Any Point During the Randomized Phase | Response was defined as a subject having serum potassium (sK+) within 3.5-5.0 mmol/L at the EOT visit, and no use of rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period. Participants who used rescue therapy for hyperkalaemia at any point during the randomized placebo-controlled period were assigned a non-response. Participants who died prior to the EOT visit were treated as non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. | Full analysis set | Posted | Count of Participants | Participants | Day 1 of randomization phase to Day 29 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Serum Bicarbonate at Day 29 | Least-squares mean calculated with a repeated measures analysis of covariance model where the dependent variable was post randomization serum bicarbonate and with fixed terms for randomized treatment group and serum bicarbonate. | Full analysis set | Posted | Least Squares Mean | Standard Error | mmol/L | Day 29 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 3 mmol/L From Baseline to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Occurrence (yes/no) of participants having an increase in serum bicarbonate of greater than or equal to 3 mmol/L from baseline (Day 1) to EOT (Day 29) without need for rescue treatment for metabolic acidosis (low bicarbonate). Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Full analysis set | Posted | Count of Participants | Participants | Day 1 to Day 29 of randomization phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence (Yes/no) of Participants Having Serum Bicarbonate ≥22 mmol/L | Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for low bicarbonate. Participants who had used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who died prior to the EOT visit were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. | Full analysis set | Posted | Count of Participants | Participants | Day 1 to Day 29 of randomization phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence (Yes/no) of Participants Having an Increase in Serum Bicarbonate of Greater Than or Equal to 2 mmol/L From Baseline (Day 1) to EOT Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) | Response was defined as a participant with an increase in serum bicarbonate greater than or equal to 2 mmol/L at the EOT visit and no use of rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate at any point during the randomized placebo-controlled period had their last observation prior to rescue therapy carried forward. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Full analysis set | Posted | Count of Participants | Participants | Day 1 to Day 29 of randomization phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Having Normal sK+ at EOT and an Increase in Serum Bicarbonate of ≥3 mmol/L From Baseline Without Need for Rescue Treatment for Metabolic Acidosis (Low Bicarbonate) or Hyperkalemia | Participants with normal sK+ between 3.5 and 5.0 mmol/L inclusive at EOT and increase in serum bicarbonate greater than or equal to 3 mmol/L from Day 1 without rescue treatment for metabolic acidosis (low bicarbonate) or hyperkalemia. Response was a participant with sK+ within 3.5-5.0 mmol/L and increase in serum bicarbonate greater than or equal to 3 mmol/L at the EOT visit and no use of rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period. Participants who used rescue therapy for low bicarbonate or HK during the randomized placebo-controlled period had last observation prior to rescue therapy carried forward. Participants lost to follow-up prior to EOT visit had response as missing. Logistic regression model included response status (response/non-response) as dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Full analysis set | Posted | Count of Participants | Participants | Day 1 to Day 29 of randomization phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence (Yes/no) of Patients Having a Normal sK+ Between 3.5 and 5.0 mmol/L Inclusive and Bicarbonate ≥22 mmol/L at Day 29 Without Need for Rescue Treatment for Hyperkalemia or Metabolic Acidosis (Low Bicarbonate) | Response was defined as a participant with sK+ within 3.5-5.0 mmol/L and serum bicarbonate greater than or equal to 22 mmol/L at the EOT visit without the need for rescue therapy for hyperkalaemia or low bicarbonate. Participants who used rescue therapy for hyperkalaemia or low bicarbonate at any point during the randomized placebo-controlled period were assigned a non-response. Participants who were lost to follow-up prior to the EOT visit had response treated as missing. Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor. Participants who died prior to the EOT visit were assigned a non-response. | Full analysis set | Posted | Count of Participants | Participants | Day 1 to Day 29 of randomization phase |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence (Yes/no) of Participants Needing Rescue Treatment for Low Sodium Bicarbonate | Occurrence (yes/no) of participants needing rescue treatment for low sodium bicarbonate any time during the randomized phase | Full analysis set | Posted | Count of Participants | Participants | Day 1 to Day 29 of randomization phase |
|
|
Adverse events were collected at screening, during the open-label correction phase (Days 1 and 2), throughout the treatment period of the the randomization phase (Days 2 or 3 to 29 or 30 [end of treatment] or discontinuation), and during the follow up phase (Day 36 to 39).
Adverse events were collected from the start of the open-label correction phase throughout the treatment period and including the follow-up period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-Label Phase | Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). | 0 | 38 | 0 | 38 | 1 | 38 |
| EG001 | Sodium Zirconium Cyclosilicate (SZC) Double-blind Treatment Phase | Double-blind treatment phase: Double-blind TID 10 g SZC for up to 48 hours | 0 | 17 | 1 | 17 | 4 | 17 |
| EG002 | Placebo Double-blind Treatment Phase | Double-blind treatment phase: Double-blind placebo for up to 48 hours | 1 | 20 | 2 | 20 | 9 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
Due to a screening failure rate higher than expected which led to early termination of the study, only 39 (17.0%) patients entered the open-label phase. Due to the early termination of the study and small sample size, the study was underpowered for the secondary efficacy endpoints.
The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Sponsor's prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2022 | Jun 13, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D000138 | Acidosis |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000137 | Acid-Base Imbalance |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000597310 | sodium zirconium cyclosilicate |
Not provided
Not provided
Not provided
| Missed doses whilst in hospital |
|
| Investigator decision to start rescue therapy for hyperkalemia |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| 18-64 |
|
| 65-84 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| White |
|
| Yes |
|
| Stage 4 |
|
| Stage 5 |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Participants |
|
|
|
| OG001 | Placebo | Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). Double-blind treatment phase: Double-blind placebo for up to 48 hours |
|
|
|
|
|
|
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|
|
| OG001 | Placebo | Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3). Double-blind treatment phase: Double-blind placebo for up to 48 hours |
|
|
|
Open label phase: Three times daily (TID) 10 g SZC for up to 48 hours. Participants not achieving normokalemia or normokalemic at Day 2 continued in the open-label correction phase at 10 g SZC TID for an additional 24 hours and repeat point of care test on the next day (Day 3).
Double-blind treatment phase: Double-blind placebo for up to 48 hours
|
|
|
| Participants |
|
|