A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperkalemia

In brief

The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.

Key facts

Study ID: NCT03303521
Run by: AstraZeneca
People needed: 196
Starts: 2017-12-14
Expected to finish: 2018-11-07
Last updated by the study team: 2020-02-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Research Site — Los Angeles, California, United States
Research Site — Ontario, California, United States
Research Site — San Dimas, California, United States
Research Site — Whittier, California, United States
Research Site — Kansas City, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Paterson, New Jersey, United States
Research Site — Fresh Meadows, New York, United States
Research Site — Great Neck, New York, United States
Research Site — Ridgewood, New York, United States
Research Site — The Bronx, New York, United States
Research Site — East Providence, Rhode Island, United States
Research Site — El Paso, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Hamamatsu, Japan
Research Site — Kumamoto, Japan
Research Site — Miyagi-gun, Japan
Research Site — Nagano, Japan
Research Site — Niigata, Japan
Research Site — Ora-gun, Japan
Research Site — Osaka, Japan
Research Site — Sakaishi, Japan
Research Site — Sashima-gun, Japan
Research Site — Sendai, Japan
Research Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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