Status:
COMPLETED
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalemia
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Female or male aged ≥ 18 years at screening Visit 1. For patients aged \<20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of endstage renal disease (ESRD) for at least 3 months before randomization.
- Patients must have hemodialysis access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study.
- Pre-dialysis serum K \>5.4 mmol/L after long inter-dialytic interval and \>5.0 mmol/L after one short inter-dialytic interval during screening (as assessed by central lab).
- Prescribed dialysate K concentration ≤ 3 mmol/L during screening
- Sustained Qb ≥200 ml/min and spKt/V ≥1.2 (or URR ≥ 63) on stable hemodialysis/hemodiafltration prescription during screening with prescription (time, dialyzer, blood flow \[Qb\], dialysate flow rate \[Qd\] and bicarbonate concentration) expected to remain unchanged during study
- Heparin dose (if used) must be stable during screening and expected to be stable during the study
- Subjects must be receiving dietary counseling appropriate for ESRD patients treated with hemodialysis/hemodiafiltration as per local guidelines, which includes dietary potassium restriction.
Exclusion
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, including ZS Pharma staff and/or staff at the study site)
- Hemoglobin \<9 g/dL on screening (as assessed on Visit 1)
- Lack of compliance with hemodialysis prescription (both number and duration of treatments) during the two-week period preceding screening (100% compliance required)
- Patients treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS, Resonium calcium) or patiromer (Veltassa) within 7 days before screening or anticipated in requiring any of these agents during the study
- Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to randomization
- Laboratory diagnosis of hypokalemia (K \< 3.5 mmol/L), hypocalcemia (Ca \< 8.2 mg/dL; for Japan hypocalcemia is defined as albumin-corrected Ca \< 8.0 mg/dL), hypomagnesemia (Mg \< 1.7 mg/dL) or severe acidosis (serum bicarbonate 16 mEq/L or less) in the 4 weeks preceding randomization
- Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable).
- Severe leukocytosis (\>20× 10\^9/L) or thrombocytosis (≥450 × 10\^9/L) during screening
- Polycythemia (Hb \>14 g/dL) during screening
- Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization
- Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
- Patients unable to take oral ZS drug mix
- Scheduled date for living donor kidney transplant
- Patients with a life expectancy of less than 6 months
- Female patients who are pregnant or breastfeeding
- Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
- Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
- Participation in another clinical study with an investigational product during the last 1 month before screening
- Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation
- Presence of cardiac arrhythmias or conduction defects that require immediate treatment
- History of alcohol or drug abuse within 2 years prior to randomization
- Previous randomization in the present study
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03303521
Start Date
December 14 2017
End Date
November 7 2018
Last Update
February 20 2020
Active Locations (53)
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1
Research Site
Los Angeles, California, United States, 90022
2
Research Site
Los Angeles, California, United States, 90025
3
Research Site
Ontario, California, United States, 91762
4
Research Site
San Dimas, California, United States, 91773