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Trial record 80 of 119 for:    ZIRCONIUM

A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia (HARMONIZE GL)

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ClinicalTrials.gov Identifier: NCT02875834
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of initial ZS therapy (10g TID).

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Sodium Zirconium Cyclosilicate (ZS) 10g Drug: Sodium Zirconium Cyclosilicate (ZS) 5g Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ZS, in Patients With Hyperkalemia-HARMONIZE Global
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Arm Intervention/treatment
Experimental: Sodium Zirconium Cyclosilicate (ZS) 5g
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Drug: Sodium Zirconium Cyclosilicate (ZS) 5g
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.

Experimental: Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Drug: Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)

Drug: Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.

Placebo Comparator: Placebo
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Drug: Placebo
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.




Primary Outcome Measures :
  1. Least Square Mean S-K level on days 8-29 [ Time Frame: Through 28-day randomized treatment study phase day 8-29 ]
    Comparison between placebo and the active ZS treatment groups (each dose group will be sequentially compared with placebo, starting with the highest and ending with the lowest dose) with regard to the mean S-K level during the 28-day randomized treatment study phase Days 8-29


Secondary Outcome Measures :
  1. Proportion of patients achieving normokalemia [ Time Frame: Through 48-hour initial phase ]
    Proportion of patients who achieve normokalemia during the initial phase at 24 and 48 hours

  2. Exponential rate of change in S-K levels [ Time Frame: Through 48-hour initial phase ]
    Exponential rate of change in S-K levels (blood) during the 48-hour open-label initial phase

  3. Change from baseline in S-K levels [ Time Frame: Through 48-hour initial phase ]
    Change (absolute and percent change) from baseline in S-K levels at all measured time intervals

  4. Time to normalization in S-K levels [ Time Frame: Through 48-hour initial phase ]
    Time to normalization in S-K levels in 48-hour open-label initial phase

  5. Proportion of patients remaining normokalemic [ Time Frame: Through 28-day randomized treatment phase ]
    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 phase

  6. Days patients remain normokalemic [ Time Frame: Through 28-day randomized treatment phase ]
    The number of days patients remain normokalemic during the 28-day randomized treatment study phase

  7. Mean change and mean percent change in S-K levels [ Time Frame: Through 28-day randomized treatment phase ]
    The mean change and mean percent change in S-K levels evaluated relative to both baselines

  8. Time to hyperkalemia [ Time Frame: Through 28-day randomized treatment phase ]
    The time to hyperkalemia (defined as S-K ≥ 5.1mmol/l)

  9. Mean changes in S-Aldosterone and P Renin levels [ Time Frame: Through 28-day randomized treatment phase ]
    The mean changes in S-Aldosterone and P-Renin levels

  10. Patient reported health state (EQ-5D questionnaire) [ Time Frame: Through study completion, an average of 37 days ]
    Evaluate health state of patients using EQ-5D


Other Outcome Measures:
  1. Serum calcium (S-Ca) [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the effect of ZS on S-Ca in both 48-hour open label initial phase and 28-day randomized treatment study phase

  2. Serum magnesium (S-Mg) [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the effect of ZS on S-Mg in both 48-hour open label initial phase and 28-day randomized treatment study phase

  3. Serum sodium (S-Na) [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the effect of ZS on S-Na in both 48-hour open label initial phase and 28-day randomized treatment study phase

  4. Serum phosphate (S-PO4) [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the effect of ZS on S-PO4 in both 48-hour open label initial phase and 28-day randomized treatment study phase

  5. Serum bicarbonate (S-HCO3) [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the effect of ZS on S-HCO3 in both 48-hour open label initial phase and 28-day randomized treatment study phase

  6. Blood urea nitrogen (BUN) [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the effect of ZS on BUN in both 48-hour open label initial phase and 28-day randomized treatment study phase

  7. AEs, SAEs, vital signs,physical examinations,ECG and clinical laboratory evaluations [ Time Frame: Through study completion, an average of 37 days ]
    To evaluate the safety and tolerability profiles of ZS in both 48-hour open label initial phase and 28-day randomized treatment study phase



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Female and male patients aged ≥18 and ≤ 90 years
  • 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
  • Ability to have repeated blood draws or effective venous catheterization
  • Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy.

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study
  • Participation in another clinical study with an investigational product during the last 3 months
  • Pseudohyperkalemia signs and symptoms
  • 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 treated with resins,calcium acetate,calcium carbonate, or lanthanum carbonate,within 7 days prior to the first dose of study drug
  • Patients with a life expectancy of less than 3 months
  • Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol
  • Female patients who are pregnant, lactating, or planning to become pregnant
  • Patients with diabetic ketoacidosis
  • 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
  • Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
  • Patients with cardiac arrhythmias that require immediate treatment
  • Patients on dialysis
  • Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of ZS

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): NCT02875834


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Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02875834     History of Changes
Other Study ID Numbers: D9480C00002
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018

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