Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 119 for:    ZIRCONIUM

Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03172702
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Zirconium Cyclosilicate Phase 3

Detailed Description:
The study will start with the screening period, and all baseline parameters should be measured/collected up to 1 day prior to administration of first dose of study drug on Correction Phase Day 1. Subjects with 2 consecutive i-STAT potassium values ≥ 5.1 mmol/L will enter the Correction Phase and receive ZS 10 g TID for up to 72 hours, depending on potassium values. Once normokalemia (i-STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be entered into the Maintenance Phase to be dosed with ZS at a starting dose of 5 g QD. Potassium (i-STAT and Central Laboratory) will be measured Days 1, 2, 5, 12, 19 and 26 throughout the first month of study and every 4 weeks thereafter until Day 362 (Visit 23) then patients will be required to complete the EOS visit which is 7±1 days after the last administration of study medication. For patients who do not enter the Maintenance Phase the last visit will be 7±1 day after the last treatment dose in the Correction Phase. The total expected study duration for an individual patient is approximately 53-54 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : July 6, 2019
Actual Study Completion Date : July 6, 2019

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
Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.
Drug: Zirconium Cyclosilicate
Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.
Other Name: ZS




Primary Outcome Measures :
  1. Safety and Tolerability of long-term dosing with ZS. [ Time Frame: Up to 12 months ]

    To assess open-label, long-term (12 months) safety and tolerability for ZS in Japanese subjects with hyperkalemia (serum potassium ≥ 5.1 mmol/L).

    Safety and tolerability as measured by adverse events reporting, vital signs, ECGs, physical examinations, and safety laboratory measurements.



Secondary Outcome Measures :
  1. The proportion of subjects who can maintain normokalemia. [ Time Frame: Up to 12 months ]
    To evaluate the proportion of ZS-treated subjects in whom normokalemia can be maintained over prolonged periods of time, using an individually titrated dose (5 g every other day [or 2.5 g once daily], 5 g once daily, 10 g once daily or 15 g once daily)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (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.
  • Patients aged ≥18. For patients aged <20 years, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
  • Two consecutive i-STAT potassium values, measured 60-minutes (± 15 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction Phase Study Day 1.
  • Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5 and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1 hour apart are required). i-STAT potassium measurement should be performed in the morning before breakfast and in the evening before dinner in PD patients on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD), respectively.
  • Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test within 1 day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 1 year are not considered to be of childbearing potential.

Exclusion Criteria:

  • Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS.
  • Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug. Washout of SPS and CPS for 7 days (or longer) prior to the first dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically acceptable by the investigator. Documented informed consent has to be obtained prior to the washout.
  • Patients with a life expectancy of less than 12 months
  • Female patients who are pregnant, lactating, or planning to become pregnant
  • Patients who have an active or history of diabetic ketoacidosis
  • Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
  • Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
  • Patients with cardiac arrhythmias that require immediate treatment
  • Hemodialysis patients (including those who are on both PD and hemodialysis [HD])
  • Patients who have been on PD less than 6 months or more than 6 months with a history of hypokalemia within 6 months before Correction Phase Day 1
  • Documented Glomerular Filtration Rate (GFR) < 15 mL/min within 90 days prior to study entry (Non peritoneal dialysis (PD) patients only)
  • If patients joined ZS study in the past, the patients cannot join this study within the last 30 days of the last study drug administration day.

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): NCT03172702


Locations
Layout table for location information
Japan
Research Site
Akashi-shi, Japan, 674-0063
Research Site
Amagasaki-shi, Japan, 660-8550
Research Site
Chiba-shi, Japan, 260-8712
Research Site
Chiba-shi, Japan, 263-0043
Research Site
Chiyoda-ku, Japan, 101-0047
Research Site
Chuo-ku, Japan, 103-0027
Research Site
Funabashi-shi, Japan, 273-8588
Research Site
Hanyu-shi, Japan, 348-8505
Research Site
Higashiibaraki-gun, Japan, 311-3193
Research Site
Hitachinaka-shi, Japan, 312-0057
Research Site
Ina-shi, Japan, 396-8555
Research Site
Kagoshima-shi, Japan, 892-8580
Research Site
Kahoku-gun, Japan, 920-0293
Research Site
Kamakura-shi, Japan, 247-8533
Research Site
Kasuga-shi, Japan, 816-0864
Research Site
Kasugai-shi, Japan, 486-8510
Research Site
Kasugai-shi, Japan, 487-0016
Research Site
Kawachinagano-shi, Japan, 586-8521
Research Site
Kawasaki-shi, Japan, 216-8511
Research Site
Kitakyushu-shi, Japan, 802-0001
Research Site
Kochi-shi, Japan, 780-0082
Research Site
Koga-shi, Japan, 306-0014
Research Site
Koga-shi, Japan, 306-0041
Research Site
Kumamoto-shi, Japan, 861-8520
Research Site
Matsudo-shi, Japan, 271-0077
Research Site
Matsuyama-shi, Japan, 791-8026
Research Site
Minokamo-shi, Japan, 505-8503
Research Site
Mito-shi, Japan, 311-4153
Research Site
Nagoya-shi, Japan, 457-8511
Research Site
Naka-shi, Japan, 311-0113
Research Site
Omura-shi, Japan, 856-8562
Research Site
Onomichi-shi, Japan, 732-8503
Research Site
Osaka-shi, Japan, 530-0001
Research Site
Osaka-shi, Japan, 558-8558
Research Site
Osaka-shi, Japan, 559-0012
Research Site
Shimajiri-gun, Japan, 901-0493
Research Site
Shizuoka-shi, Japan, 421-0117
Research Site
Toride-shi, Japan, 302-0022
Research Site
Toshima-ku, Japan, 170-0003
Research Site
Toyohashi-shi, Japan, 441-8570
Research Site
Yao-shi, Japan, 581-0011
Research Site
Yotsukaido-shi, Japan, 284-0027
Sponsors and Collaborators
AstraZeneca

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03172702     History of Changes
Other Study ID Numbers: D9482C00001
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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