ClinicalTrials.Veeva

Menu

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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Hyperkalemia

Treatments

Drug: Sodium Zirconium Cyclosilicate (ZS) 5g
Drug: Sodium Zirconium Cyclosilicate (ZS) 10g
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02875834
D9480C00002

Details and patient eligibility

About

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).

Enrollment

267 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

267 participants in 3 patient groups, including a placebo group

Sodium Zirconium Cyclosilicate (ZS) 5g
Experimental group
Description:
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Treatment:
Drug: Sodium Zirconium Cyclosilicate (ZS) 5g
Sodium Zirconium Cyclosilicate (ZS) 10g
Experimental group
Description:
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Treatment:
Drug: Sodium Zirconium Cyclosilicate (ZS) 10g
Drug: Sodium Zirconium Cyclosilicate (ZS) 10g
Placebo
Placebo Comparator group
Description:
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

45

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems