A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
HARMONIZE GL
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
1 other identifier
interventional
267
4 countries
45
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2017
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2018
CompletedResults Posted
Study results publicly available
August 19, 2020
CompletedAugust 19, 2020
August 1, 2020
12 months
July 22, 2016
February 12, 2019
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Least Square Mean S-K Level on Days 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. The results in the table below are presented for RTP.
Through 28-day randomized treatment study phase day 8-29.
Secondary Outcomes (12)
Proportion of Patients Achieving Normokalemia
Through 48-hour initial phase.
Exponential Rate of Change in S-K Levels
Through 48-hour initial phase.
Absolute Change From Baseline in S-K Levels
Through 48-hour initial phase.
Percentage Change From Baseline in S-K Levels
Through 48-hour initial phase.
Proportion of Patients Remaining Normokalemic
Through 28-day randomized treatment study phase day 8-29.
- +7 more secondary outcomes
Study Arms (3)
Sodium Zirconium Cyclosilicate (ZS) 5g
EXPERIMENTALSuspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Sodium Zirconium Cyclosilicate (ZS) 10g
EXPERIMENTALSuspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Placebo
PLACEBO COMPARATORSuspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Interventions
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)
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (45)
Research Site
Chiba, 260-8712, Japan
Research Site
Hanyu-shi, 348-8505, Japan
Research Site
Hitachi-Naka, 312-0057, Japan
Research Site
Ina-shi, 396-8555, Japan
Research Site
Kanazawa, 920-8650, Japan
Research Site
Koga-shi, 306-0041, Japan
Research Site
Matsudo-shi, 271-0077, Japan
Research Site
Nagoya, 457-8511, Japan
Research Site
Nagoya, 462-0802, Japan
Research Site
Shimajiri-gun, 901-0493, Japan
Research Site
Shizuoka, 421-0117, Japan
Research Site
Toride-shi, 302-0022, Japan
Research Site
Toyohashi, 441-8570, Japan
Research Site
Yakushi, 581-0011, Japan
Research Site
Krasnoyarsk, 660062, Russia
Research Site
Moscow, 123423, Russia
Research Site
Saint Petersburg, 194354, Russia
Research Site
Saint Petersburg, 196601, Russia
Research Site
Yaroslavl, 150062, Russia
Research Site
Yekaterinburg, 620039, Russia
Research Site
Anyang-si, 14068, South Korea
Research Site
Bucheon-si, 14647, South Korea
Research Site
Bucheon-si, 14754, South Korea
Research Site
Busan, 49241, South Korea
Research Site
Cheongju-si, 28644, South Korea
Research Site
Goyang-si, 10380, South Korea
Research Site
Goyang-si, 10444, South Korea
Research Site
Gwangju, 61469, South Korea
Research Site
Hwaseong-si, 18450, South Korea
Research Site
Incheon, 403-720, South Korea
Research Site
Incheon, 405-760, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03312, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 07061, South Korea
Research Site
Seoul, 08308, South Korea
Research Site
Suwon, South Korea
Research Site
Uijeongbu-si, 11765, South Korea
Research Site
Wŏnju, 26426, South Korea
Research Site
Hualien City, 970, Taiwan
Research Site
New Taipei City, 231, Taiwan
Research Site
Taichung, 402, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, ROC 100, Taiwan
Research Site
Taipei, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
August 23, 2016
Study Start
March 3, 2017
Primary Completion
February 14, 2018
Study Completion
February 14, 2018
Last Updated
August 19, 2020
Results First Posted
August 19, 2020
Record last verified: 2020-08