Health Condition 1: E875- Hyperkalemia
Conditions
Interventions
Intervention1: Sodium Zirconium Cyclosilicate: Drug: Sodium Zirconium Cyclosilicate
Suspension administered Sodium Zirconium Cyclosilicate orally once daily for 28 days after the first 48-hour open
Sponsors
AstraZeneca AB
Eligibility
Inclusion criteria
Inclusion criteria: Optional Pre-screening part of the study For inclusion in the study patients should fulfill the following criteria: 1. Provision of informed consent (pre-screening consent) prior to any study specific procedures 2. Female and male patients aged >=18 and Main part of the study Above inclusion criteria 2 is also applied to the Main part of the study. In addition, for inclusion in the study patients should fulfill the following criteria: 3. Provision of informed consent prior to any study specific procedures 4. Two consecutive i-STAT potassium values, measured 60-minutes (± 10 minutes) apart, both >= 5.1 mmol/L and measured within 1 day of the first ZS dose on 48- hour open-label initial phase Day 1 5.Ability to have repeated blood draws or effective venous catheterization 6.Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable;additional barrier methods in conjunction with spermicide must be used 7. Patient must have at least one of the following risk factors for Hyperkalemia (a) Chronic Kidney Disease (b) Heart Failure (c) Diabetes Mellitus 8. Documented evidence of at least 2 episodes of hyperkalemia with serum potassium level of >= 5.1 mmol/l at least one week apart within 6 months prior to informed consent.
Exclusion criteria
Exclusion criteria: Optional Pre-screening part of the study 1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2.Participation in another clinical study with an investigational product during the last 3 months 3.Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardizes the quality of the data to be generated Main part of the study Above exclusion criteria are also applied to the Main part of the study. In addition, patients should not enter the study if any of the following exclusion criteria are fulfilled: 4.Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venepuncture, or history of severe leukocytosis or thrombocytosis 5.Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug 6.Patients treated with resins (such as sevelamer acetate or sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug 7.Patients with a life expectancy of less than 3 months 8.Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjectsâ?? tasks associated with the protocol 9.Female patients who are pregnant, lactating, or planning to become pregnant 10.Patients with diabetic ketoacidosis 11.Known hypersensitivity or previous anaphylaxis to ZS or to components thereof 12.Patients with cardiac arrhythmias that require immediate treatment 13.Patients on dialysis 14.Patients who are blood donors should not donate blood during the study and for 3months following their last dose of ZS 15.Patients who need hospitalization after taking blood samples on day 1 of the 48- hour open-label initial phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between placebo and each ZS treatment group (high to low) with regard to the mean S-K level during the 28-day randomized treatment study phase days 8 - 29Timepoint: Comparison between placebo and each ZS treatment group (high to low) with regard to the mean S-K level during the 28-day randomized treatment study phase days 8 - 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Exponential rate of change in Serum potassium levels (blood) during the 48-hour open-label initial phaseTimepoint: 48 hours;Mean change (absolute and percent change) from baseline in S-K levels (blood) at all measured time intervals post dose in the 48- hour open-label initial phaseTimepoint: 48 Hours;Proportion of patients who achieve normokalemia during the 48-hour open-label initial phase at 24 and 48 hoursTimepoint: 48 hours;The mean change and mean percent change in SK levels evaluated relative to both baselinesTimepoint: 28 Days;The mean changes in S-Aldo and P-Renin levelsTimepoint: 28 Days;The number of days patients remain normokalemic during the 28-day randomized treatment study phaseTimepoint: 28 days;The proportion of patients who remain normokalemic (as defined by S-K between 3.5- 5.0 mmol/L, inclusive) at the end of the 28-day randomized treatment study phase and during the 28-day randomized treatment study phaseTimepoint: 28 days;The time to hyperkalemia (defined as S-K â?¥ 5.1mmol/L)Timepoint: 28 days;Time to normalization in S-K levels (normalization defined as S-K levels between 3.5-5.0 mmol/L, inclusive) in the 48-hour open label initial phaseTimepoint: 48 hours | — |
Countries
China, India
Contacts
Public ContactMr Tapankumar M Shah
AstraZeneca Pharma India Ltd
Outcome results
None listed