HyperkalemiaPhase 2NCT03799926
Exploratory Study of ZG-801 for the Treatment of Hyperkalemia
A Phase 2 study testing patiromer in people with Hyperkalemia, run by Zeria Pharmaceutical at 1 site in Japan.
Trial summary
To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients. To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- patiromer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteJapan
- Study dates
- 18 Feb 2019to 2 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ages 18 - 80
- Informed consent given
- Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)
Who cannot join
- Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
- Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
- Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
- Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
- Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
Show all 9Show fewer
- Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
- Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
- Subjects suspected of transient high potassium levels, such as those caused only by dietary effects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -
To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.
To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
- Conditions
- Hyperkalemia
- Being tested
- patiromer, placebo
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patiromerDrug
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
patiromerDrug
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
placeboDrug
Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
placeboDrug
Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
patiromerDrug
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
patiromerDrug
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
patiromerDrug
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
patiromerDrug
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1: 8.4 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Receives: Drug: patiromer |
| Stratum 1: 16.8 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Receives: Drug: patiromer |
| Stratum 1: placebo of 8.4 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Receives: Drug: placebo |
| Stratum 1: placebo of 16.8 g patiromer | Experimental | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline Receives: Drug: placebo |
| Stratum 2: 8.4 g patiromer | Experimental | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline Receives: Drug: patiromer |
| Stratum 2: 16.8 g patiromer | Experimental | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline Receives: Drug: patiromer |
| Stratum 3: 8.4 g patiromer | Experimental | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline Receives: Drug: patiromer |
| Stratum 3: 16.8 g patiromer | Experimental | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline Receives: Drug: patiromer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
Measured: Baseline to week 1
Secondary outcomes (4)
Change in serum potassium 4 weeks after the start of administration in each group of starting dose
Measured: Baseline to week 4
Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose
Measured: Week 4
Incidence of adverse events
Measured: Over 52-week study period
Incidence of adverse drug reactions
Measured: Over 52-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start18 Feb 2019
- Primary completion6 Nov 2019
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799926
- Sponsor's protocol ID
- ZG-801-01
- Status last verified
- Mar 2021
- First submitted
- 8 Jan 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -
- ClinicalTrials.gov ID
- NCT03799926
- Acronym / sponsor ID
- ZG-801-01
- Conditions
- Hyperkalemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.
To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Stratum 1: 8.4 g patiromer | Experimental | Drug: patiromerNon-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
| Stratum 1: 16.8 g patiromer | Experimental | Drug: patiromerNon-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
| Stratum 1: placebo of 8.4 g patiromer | Experimental | Drug: placeboNon-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
| Stratum 1: placebo of 16.8 g patiromer | Experimental | Drug: placeboNon-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline |
| Stratum 2: 8.4 g patiromer | Experimental | Drug: patiromerNon-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline |
| Stratum 2: 16.8 g patiromer | Experimental | Drug: patiromerNon-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline |
| Stratum 3: 8.4 g patiromer | Experimental | Drug: patiromerDialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline |
| Stratum 3: 16.8 g patiromer | Experimental | Drug: patiromerDialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females ages 18 - 80
- Informed consent given
- Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)
Key exclusion criteria (9 listed)
- Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
- Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
- Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
- Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patiromerPatiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Drug | Stratum 1: 8.4 g patiromer |
| patiromerPatiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Drug | Stratum 1: 16.8 g patiromer |
| placeboPlacebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Drug | Stratum 1: placebo of 8.4 g patiromer |
| placeboPlacebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Drug | Stratum 1: placebo of 16.8 g patiromer |
| patiromerPatiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) | Drug | Stratum 2: 8.4 g patiromer |
| patiromerPatiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) | Drug | Stratum 2: 16.8 g patiromer |
| patiromerPatiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) | Drug | Stratum 3: 8.4 g patiromer |
| patiromerPatiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) | Drug | Stratum 3: 16.8 g patiromer |
Primary outcome
Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
Time frame: Baseline to week 1
4 secondary outcomes
Change in serum potassium 4 weeks after the start of administration in each group of starting dose
Time frame: Baseline to week 4
Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose
Time frame: Week 4
Incidence of adverse events
Time frame: Over 52-week study period
Incidence of adverse drug reactions
Time frame: Over 52-week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing patiromer in people with Hyperkalemia, run by Zeria Pharmaceutical at 1 site in Japan.
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 9 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose (time frame: Baseline to week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2021.