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HyperkalemiaPhase 3NCT02107092

Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.

A Phase 3 study testing Sodium Zirconium Cyclosilicate in people with Hyperkalemia, run by ZS Pharma, Inc. at 49 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperkalemia
What is being tested?
Sodium Zirconium Cyclosilicate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
49 sitesin 3 countries
Study dates
31 May 2014to 31 Aug 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of written informed consent.
  • Completed the ZS-004 DBRMP Study Day 29 visit or discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia and able to start dosing in ZS-004E within two (2) days after the last dose of Investigational product in ZS-004.
  • Subject must have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive at the ZS-004 DBRMP Study Day 29 visit or a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive if the subject discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia .

Who cannot join

  • Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, history of severe leukocytosis or thrombocytosis.
  • Subjects who received alternative treatment for hyperkalemia while participating in study ZS-004.
  • Subjects with a life expectancy of less than 3 months.
  • Subjects 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.
  • Women who are pregnant, lactating, or planning to become pregnant.
  • Subjects with diabetic ketoacidosis.
Show all 11Show fewer
  • Presence of any condition which, in the opinion of the investigator, places the subject 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.
  • Treatment with a drug or device other than ZS within the last 30 days that has not received regulatory approval at the time of study entry.
  • Subjects with cardiac arrhythmias that require immediate treatment.
  • Subjects on dialysis.

Trial locations and contacts

49 sites in 3 countries.

49 sites in 3 countries

United States41 sites

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Atlantis, Florida, 33462

  • Study site

    Auburn, Maine, 04210

  • Study site

    Bradenton, Florida, 34208

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Chattanooga, Tennessee, 37408

  • Study site

    Chesterfield, Michigan, 48047

  • Study site

    Columbus, Georgia, 31901

  • Study site

    Decatur, Georgia, 30030

  • Study site

    DeLand, Florida, 32720

  • Study site

    Edgewater, Florida, 32132

  • Study site

    Evergreen Park, Illinois, 60805

  • Study site

    Flushing, New York, 11355

  • Study site

    Hawaiian Gardens, California, 90716

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Kansas City, Missouri, 64411

  • Study site

    Las Vegas, Nevada, 89115

  • Study site

    Los Angeles, California, 90022

  • Study site

    Miami, Florida, 33015

  • Study site

    Miami, Florida, 33125

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Miami Lakes, Florida, 33018

  • Study site

    New Smyrna Beach, Florida, 32168

  • Study site

    Ocala, Florida, 34471

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Paramount, California, 90723

  • Study site

    Phoenix, Arizona, 85027

  • Study site

    Providence, Rhode Island, 02903

  • Study site

    Riverside, California, 92505

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Scottsboro, Alabama, 35768

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Summerfield, Florida, 34491

  • Study site

    Sumter, South Carolina, 29150

  • Study site

    Tampa, Florida, 33607

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tempe, Arizona, 85284

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

Australia5 sites

  • Study site

    Gosford, New South Wales

  • Study site

    Heidelberg, Victoria

  • Study site

    Melbourne, Victoria

  • Study site

    Parkville, Victoria

  • Study site

    Woolloongabba, Queensland

Other trials in Australia

South Africa3 sites

  • Study site

    Meyerspark

  • Study site

    Port Elizabeth

  • Study site

    Somerset West

Other trials in South Africa

About this study

Official title: Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]

Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.

Read the detailed description

All subjects with i-STAT potassium values between 3.5-5.5 mmol/l, inclusive at the ZS-004 (NCT 02088073) DBRMP Study Day 29 visit, who continue directly into the open-label extension study ZS-004E (NCT 021070920), will enter the Maintenance Phase (MP) and start on open-label ZS at a dose of 10g qd. All subjects with i-STAT potassium values > 5.5 mmol/l at the ZS-004 DBRMP Study Day 29 visit will undergo an acute treatment phase (AP) where they will receive ZS 10g three times a day (tid) for 24 (3 doses) or 48 hours (6 doses). If the subject's i-STAT potassium is between 3.5-5.0 mmol/l, inclusive after 24 (AP Study Day 2) or 48 hours (AP Study Day 3), the subject will enter the MP at a starting dose of 10g qd.

For subjects who discontinued during ZS-004 DBRMP due to hypo- or hyperkalemia baseline potassium values will be determined within 1 day of administration of the first dose in the ZS-004E extension study by taking two (2) consecutive i-STAT potassium measurements at 0 and 60 minutes (± 10 minutes). If the mean i-STAT value is between 3.5 - 5.5 mmol/l, inclusive, the subject will enter directly into the MP and receive 10g ZS qd; if the mean i-STAT potassium value is > 5.5 mmol/l, the subject will enter the AP. If i-STAT potassium values are still >5.0 mmol/l on the morning of AP Study Day 3, subjects will not enter the MP but will be referred to their normal health care provider for standard of care.

If the i-STAT potassium value increases above 5.5 mmol/l during the MP with treatment at 10g qd, the dose can be increased to15g qd. Conversely, if S-K decreases to between 3.0-3.4 mmol/l, inclusive, the dose of ZS can be decreased in 5g qd, decrements. If a subject is on a 5g qd dose and still develops blood potassium i-STAT values between 3.0 - 3.4mmol, inclusive the dose can be reduced to 5g every other day.

Subjects will receive up to 11 months of treatment with open-label ZS.

Conditions
Hyperkalemia
Being tested
Sodium Zirconium Cyclosilicate
Medical subject headings
Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium Zirconium CyclosilicateDrug

    Also called ZS

    Oral 10g once daily with breakfast for 11 months.

Study groups in NCT02107092
Study groupRoleWhat they receive
Sodium Zirconium CyclosilicateExperimentalOpen label oral administration of sodium zirconium cyclosilicate 10g once daily for 11 months.
Receives: Drug: Sodium Zirconium Cyclosilicate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L

    The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive

    Measured: 11 months

Secondary outcomes (1)

  1. Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L

    The proportions of subjects with average S-K values ≤ 5.5 mmol/L during Extended Dosing Study Days 8 to 337, inclusive

    Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study start31 May 2014
  3. Primary completion31 Jul 2015
  4. Study completion31 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107092
Sponsor's protocol ID
ZS-004E
Status last verified
Jul 2018
First submitted
3 Apr 2014
Last updated
15 Aug 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium Zirconium Cyclosilicate in people with Hyperkalemia, run by ZS Pharma, Inc. at 49 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Australia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L (time frame: 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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