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Trial record 35 of 119 for:    ZIRCONIUM

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

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ClinicalTrials.gov Identifier: NCT03303521
Recruitment Status : Completed
First Posted : October 6, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Placebo Drug: Sodium Zirconium Cyclosilicate (ZS) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate (DIALIZE)
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Sodium Zirconium Cyclosilicate (ZS)
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days.
Drug: Sodium Zirconium Cyclosilicate (ZS)

Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) .

Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days.


Placebo Comparator: Placebo
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
Drug: Placebo

Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) .

Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.





Primary Outcome Measures :
  1. Proportion of patients who maintain a pre-dialysis serum K between 4.0-5.0 mmol/L on 3 out of 4 dialysis treatments following the long interdialytic interval during the evaluation period and who do not receive rescue therapy during the evaluation period [ Time Frame: last 4 weeks of the treatment period ]

Secondary Outcome Measures :
  1. Number of patients requiring treatment with insulin/glucose and/or beta adrenergic agonists and/or sodium bicarbonate and/or K binders and/or any form of renal replacement therapy. [ Time Frame: From screening to Week 11 ]
    Evaluate the need for rescue therapy

  2. Adverse events (AEs) [ Time Frame: From screening to Week 11 ]
    Evaluate safety of ZS in hemodialysis

  3. Changes in laboratory values [ Time Frame: From screening to Week 11 ]
    Evaluate safety of ZS in hemodialysis

  4. Physical examination [ Time Frame: From screening to Week 11 ]
    Evaluate safety of ZS in hemodialysis

  5. ECG [ Time Frame: From screening to Week 11 ]
    Evaluate safety of ZS in hemodialysis

  6. Vital signs [ Time Frame: From screening to Week 11 ]
    Evaluate safety of ZS in hemodialysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. 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.
  3. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of endstage renal disease (ESRD) for at least 3 months before randomization.
  4. 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.
  5. 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).
  6. Prescribed dialysate K concentration ≤ 3 mmol/L during screening
  7. 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
  8. Heparin dose (if used) must be stable during screening and expected to be stable during the study
  9. Subjects must be receiving dietary counseling appropriate for ESRD patients treated with hemodialysis/hemodiafiltration as per local guidelines, which includes dietary potassium restriction.

Exclusion Criteria:

  1. 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)
  2. Hemoglobin <9 g/dL on screening (as assessed on Visit 1)
  3. Lack of compliance with hemodialysis prescription (both number and duration of treatments) during the two-week period preceding screening (100% compliance required)
  4. 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
  5. 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
  6. 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
  7. 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).
  8. Severe leukocytosis (>20× 10^9/L) or thrombocytosis (≥450 × 10^9/L) during screening
  9. Polycythemia (Hb >14 g/dL) during screening
  10. Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization
  11. Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
  12. Patients unable to take oral ZS drug mix
  13. Scheduled date for living donor kidney transplant
  14. Patients with a life expectancy of less than 6 months
  15. Female patients who are pregnant or breastfeeding
  16. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
  17. Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
  18. Participation in another clinical study with an investigational product during the last 1 month before screening
  19. 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
  20. Presence of cardiac arrhythmias or conduction defects that require immediate treatment
  21. History of alcohol or drug abuse within 2 years prior to randomization
  22. Previous randomization in the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303521


  Show 53 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Steven Fishbane, MD NSUH,Dept of Medicine,300 Community Drive,Manhasset,NY11030

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03303521     History of Changes
Other Study ID Numbers: D9480C00006
2017-003029-14 ( EudraCT Number )
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases