Clinical Trial Details
| Trial ID: | L0956 |
| Source ID: | NCT04727528 |
| Associated Drug: | Sodium Zirconium Cyclosilicate |
| Title: | Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease |
| Acronym: | NEUTRALIZE |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT04727528/results |
| Conditions: | Hyperkalaemia|Metabolic Acidosis|Chronic Kidney Disease |
| Interventions: | DRUG: Sodium zirconium cyclosilicate|DRUG: Placebo |
| Outcome Measures: | 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., 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., 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), 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 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 39 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2021-03-22 |
| Completion Date: | 2022-09-14 |
| Results First Posted: | 2023-10-06 |
| Last Update Posted: | 2023-10-06 |
| Locations: | Research Site, Florence, Alabama, 35630, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, Downey, California, 90242, United States|Research Site, El Centro, California, 92243, United States|Research Site, S. 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, 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 |
| URL: | https://clinicaltrials.gov/show/NCT04727528 |
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