HyperkalemiaPhase 3NCT01737697
Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
A Phase 3 study testing Zirconium silicate (acute phase) and Zirconium silicate (subacute phase) in people with Hyperkalemia, run by ZS Pharma, Inc. at 44 sites in 2 countries.
Trial summary
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Zirconium silicate (acute phase) and Zirconium silicate (subacute phase)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 754 participants
- Where
- 44 sitesin 2 countries
- Study dates
- 30 Nov 2012to 30 Nov 2013
- 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.
- Over 18 years of age.
- Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study Day 0).
- Ability to have repeated blood draws or effective venous catheterization.
- Women of childbearing potential must be practicing a highly effective method of birth control.
Who cannot join
- Pseudohyperkalemia signs and symptoms, such as excessive fist clinching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
- Subjects treated with lactulose, xifaxan or other nonabsorbed antibiotics for hyperammonemia within the last 7 days.
- Subjects treated with resins (such as Sevelamer acetate or Sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days.
- Subjects with a life expectancy of less than 3 months.
- Subjects who are HIV positive.
- 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.
Show all 15Show fewer
- Women who are pregnant, lactating, or planning to become pregnant.
- Subjects with Ketoacidosis/Acidemia.
- 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.
- Previous treatment with ZS
- Treatment with a drug or device 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.
- Insulin-dependent diabetes mellitus
- Subjects on dialysis
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
United States42 sites
Pinnacle Research Group
Anniston, Alabama, 36207
JEM Research Institute
Atlantis, Florida, 33462
Washington Nephrology Associates
Bethesda, Maryland, 20814
The Center for Clinical Trials
Biloxi, Mississippi, 39531
United Medical Associates
Binghamton, New York, 13903
Clinical Research of Brandon
Brandon, Florida, 33511
Life Medi-Research and Management
Brooklyn, New York, 11206
Meridien Research
Brooksville, Florida, 34601
California Institute of Renal Research
Chula Vista, California, 91910
Pikes Peak Nephrology Associates
Colorado Springs, Colorado, 80909
Denver Nephrologists, PC
Denver, Colorado, 80230
Doylestown Hospital Medical Research
Doylestown, Pennsylvania, 18901
Riverside Clinical Research
Edgewater, Florida, 32123
Research by Design
Evergreen Park, Illinois, 60805
Aspire Clinical Studies, LLC
Glendale, Arizona, 85301
Southwest Houston Research, Ltd
Houston, Texas, 77099
Saadat Ansari Internal Medicine
Huntsville, Alabama, 35801
Nephrology Center DBA, Paragon Health PC
Kalamazoo, Michigan, 49007
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111
Endocrinology of Central Florida
Lake Mary, Florida, 32746
Meridien Research
Lakeland, Florida, 33805
Torrance Clinical Research
Lomita, California, 90717
Academic Medical Research Institute
Los Angeles, California, 90022
San Marcus Research Clinic
Miami, Florida, 33015
Medical Consulting Center
Miami, Florida, 33125
Elite Research Institute
Miami, Florida, 33169
Nephrology and Hypertension Associates
Middlebury, Connecticut, 06762
Prevention & Strengthening Solutions, Inc
Miramar, Florida, 33023
PCCC of Volusia
New Smyrna Beach, Florida, 32168
South Carolina Nephrology & Hypertension
Orangeburg, South Carolina, 29118
Mohammad Ismail, Inc
Paramount, California, 90723
Apex Research of Riverside
Riverside, California, 92505
Capital Nephrology Clinical Group
Sacramento, California, 95825
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Southern Utah Kidney and Hypertension Center
St. George, Utah, 84770
Meridien Research
St. Petersburg, Florida, 33709
Lakeview Medical Research
Summerfield, Florida, 34491
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150
Clinical Research Trials of Florida
Tampa, Florida, 33607
Southwest Clinical Research Institute
Tempe, Arizona, 85284
Metabolic Research Institute
West Palm Beach, Florida, 33401
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67213
Australia2 sites
Renal Research
Gosford, New South Wales, 02250
Melbourne Renal Research Group
Reservoir, Victoria, 03073
About this study
Official title: Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).
Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).
Read the detailed description
A total of 750 subjects with mild to moderate hyperkalemia (i- STAT potassium levels between 5.0-6.5 mmol/l, inclusive) will be enrolled in the study where they, in a double-blind fashion, will be randomized 1:1:1:1:1 to receive one of four (4) doses of ZS (1.25g, 2.5g, 5g, and 10g) or placebo control, administered 3 times daily (tid) with meals for the initial 48 hours (Acute Phase), followed by a Subacute Phase (randomized withdrawal) during which patients treated with active doses in the Acute Phase, who achieve normokalemia (i-STAT potassium values 3.5 to 4.9 mmol/l, inclusive) will be randomized to 12 days of subacute, once a day (qd) dosing. There will be a one-time randomization to assign the Acute Phase treatment and the Subacute Phase treatment. The Subacute Phase will include subjects who became normokalemic on active drug and those who became normokalemic on placebo. The former will be randomized in a 1:1 ratio between the same dose of ZS they received during the acute phase but only administered once a day (qd) or placebo, qd. Subjects on placebo during the Acute Phase who are normokalemic in the morning of Study Day 3, will be randomized to receive either 1.25 or 2.5 g ZS, qd as Subacute Phase treatment.
Safety and tolerability will be assessed on an ongoing basis by an Independent Data Safety Monitoring Board (DSMB). Each active dose group will consist of 150 patients per treatment group including the placebo control group for a total of 750 patients; the 1:1:1:1:1 allocation helps to optimize the multiple active dose comparisons to the respective placebo controls for the Subacute Phase.
- Conditions
- Hyperkalemia
- Being tested
- Zirconium silicate (acute phase), Zirconium silicate (subacute phase), Placebo (acute phase), Placebo ( subacute phase)
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium silicate (acute phase)Drug
Also called ZS
Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours.
Zirconium silicate (subacute phase)Drug
Also called ZS
Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days.
Placebo (acute phase)Drug
Also called Silicified microcrystalline cellulose
Randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals for 48 hours during the acute phase.
Placebo ( subacute phase)Drug
Also called Silicified microcrystalline cellulose
Randomized to mimic doses of experimental drug administered once a day prior to the morning meal for 12 days during the subacute phase.
| Study group | Role | What they receive |
|---|---|---|
| Zirconium silicate (acute phase) | Experimental | Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours. Receives: Drug: Zirconium silicate (acute phase) |
| Placebo (acute phase) | Placebo comparator | Placebo ( silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals. Receives: Drug: Placebo (acute phase) |
| Zirconium silicate (subacute phase) | Experimental | Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days. Receives: Drug: Zirconium silicate (subacute phase) |
| Placebo (subacute phase) | Placebo comparator | Placebo (silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered once a day (qd) prior to the morning meal for 12 days. Receives: Drug: Placebo ( subacute phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment.
Measured: Through 48 hours acute phase
Exponential Rate of Change in S-K Levels in the Subacute Phase.
Measured: Through 12 days subacute phase (Day 3 through Day 15)
Secondary outcomes (7)
Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment
Measured: Through 48 hours acute phase
Mean Change From Baseline in S-K at All Time Points Acute Phase
Mean change from baseline in S-K at all time points over initial 48 hours
Measured: Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.
Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase
Mean percent change from baseline in S-K at all time points over initial 48 hours
Measured: Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.
Time Subjects Remain Normokalemic (Subacute Phase)
Time (number of days) subjects remain normokalemic (3.5 - 5.0 mmol/l) subacute phase
Measured: Through 18 days (12 days treatment, 6 days follow-up) of subacute phase
Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase
Percentage of subjects within each treatment group who retained normal S-K values (values between 3.5-5.0 mmol/L) at end of subacute phase
Measured: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Mean Change From Subacute Baseline in Serum Potassium at All Time Points.
Mean change from subacute baseline in serum potassium at all time points during subacute phase
Measured: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points.
Mean percent change from subacute baseline in serum potassium at all time points during subacute phase
Measured: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study start30 Nov 2012
- Primary completion31 Oct 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZS Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Rasmussen, MD, Study chair, ZS Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737697
- Sponsor's protocol ID
- ZS-003
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2012
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
PubMed 32588430Amin AN, Menoyo J, Singh B, Kim CS. Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level >/= 5.5 mmol/L: pooled analysis from two phase 3 trials. BMC Nephrol. 2019 Dec 2;20(1):440. doi: 10.1186/s12882-019-1611-8.
PubMed 31791288Friedman PA, Scott CG, Bailey K, Baumann NA, Albert D, Attia ZI, Ladewig DJ, Yasin O, Dillon JJ, Singh B. Errors of Classification With Potassium Blood Testing: The Variability and Repeatability of Critical Clinical Tests. Mayo Clin Proc. 2018 May;93(5):566-572. doi: 10.1016/j.mayocp.2018.03.013.
PubMed 29728199Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, Qunibi W, Pergola P, Singh B. Sodium zirconium cyclosilicate in hyperkalemia. N Engl J Med. 2015 Jan 15;372(3):222-31. doi: 10.1056/NEJMoa1411487. Epub 2014 Nov 21.
PubMed 25415807
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia
- ClinicalTrials.gov ID
- NCT01737697
- Acronym / sponsor ID
- ZS-003
- Conditions
- Hyperkalemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- ZS Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2012 (actual)
- Primary completion
- 31 Oct 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).
Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).
Detailed description
A total of 750 subjects with mild to moderate hyperkalemia (i- STAT potassium levels between 5.0-6.5 mmol/l, inclusive) will be enrolled in the study where they, in a double-blind fashion, will be randomized 1:1:1:1:1 to receive one of four (4) doses of ZS (1.25g, 2.5g, 5g, and 10g) or placebo control, administered 3 times daily (tid) with meals for the initial 48 hours (Acute Phase), followed by a Subacute Phase (randomized withdrawal) during which patients treated with active doses in the Acute Phase, who achieve normokalemia (i-STAT potassium values 3.5 to 4.9 mmol/l, inclusive) will be randomized to 12 days of subacute, once a day (qd) dosing. There will be a one-time randomization to assign the Acute Phase treatment and the Subacute Phase treatment. The Subacute Phase will include subjects who became normokalemic on active drug and those who became normokalemic on placebo. The former will be randomized in a 1:1 ratio between the same dose of ZS they received during the acute phase but only administered once a day (qd) or placebo, qd. Subjects on placebo during the Acute Phase who are normokalemic in the morning of Study Day 3, will be randomized to receive either 1.25 or 2.5 g ZS, qd as Subacute Phase treatment.
Safety and tolerability will be assessed on an ongoing basis by an Independent Data Safety Monitoring Board (DSMB). Each active dose group will consist of 150 patients per treatment group including the placebo control group for a total of 750 patients; the 1:1:1:1:1 allocation helps to optimize the multiple active dose comparisons to the respective placebo controls for the Subacute Phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zirconium silicate (acute phase) | Experimental | Drug: Zirconium silicate (acute phase)Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours. |
| Placebo (acute phase) | Placebo comparator | Drug: Placebo (acute phase)Placebo ( silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals. |
| Zirconium silicate (subacute phase) | Experimental | Drug: Zirconium silicate (subacute phase)Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days. |
| Placebo (subacute phase) | Placebo comparator | Drug: Placebo ( subacute phase)Placebo (silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered once a day (qd) prior to the morning meal for 12 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent.
- Over 18 years of age.
- Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study Day 0).
- Ability to have repeated blood draws or effective venous catheterization.
- Women of childbearing potential must be practicing a highly effective method of birth control.
Key exclusion criteria (15 listed)
- Pseudohyperkalemia signs and symptoms, such as excessive fist clinching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
- Subjects treated with lactulose, xifaxan or other nonabsorbed antibiotics for hyperammonemia within the last 7 days.
- Subjects treated with resins (such as Sevelamer acetate or Sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days.
- Subjects with a life expectancy of less than 3 months.
- Subjects who are HIV positive.
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 |
|---|---|---|
| Zirconium silicate (acute phase)Also: ZSRandomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours. | Drug | Zirconium silicate (acute phase) |
| Zirconium silicate (subacute phase)Also: ZSRandomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days. | Drug | Zirconium silicate (subacute phase) |
| Placebo (acute phase)Also: Silicified microcrystalline celluloseRandomized to mimic doses of experimental drug administered 3 times (tid) daily with meals for 48 hours during the acute phase. | Drug | Placebo (acute phase) |
| Placebo ( subacute phase)Also: Silicified microcrystalline celluloseRandomized to mimic doses of experimental drug administered once a day prior to the morning meal for 12 days during the subacute phase. | Drug | Placebo (subacute phase) |
Primary outcome
Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment.
Time frame: Through 48 hours acute phase
Exponential Rate of Change in S-K Levels in the Subacute Phase.
Time frame: Through 12 days subacute phase (Day 3 through Day 15)
7 secondary outcomes
Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment
Time frame: Through 48 hours acute phase
Mean Change From Baseline in S-K at All Time Points Acute Phase
Time frame: Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.
Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase
Time frame: Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.
Time Subjects Remain Normokalemic (Subacute Phase)
Time frame: Through 18 days (12 days treatment, 6 days follow-up) of subacute phase
Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase
Time frame: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Mean Change From Subacute Baseline in Serum Potassium at All Time Points.
Time frame: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points.
Time frame: Through 18 days of subacute phase (12 days treatment, 6 days follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32588430Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
- Derived from this study: PubMed 31791288Amin AN, Menoyo J, Singh B, Kim CS. Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level >/= 5.5 mmol/L: pooled analysis from two phase 3 trials. BMC Nephrol. 2019 Dec 2;20(1):440. doi: 10.1186/s12882-019-1611-8.
- Derived from this study: PubMed 29728199Friedman PA, Scott CG, Bailey K, Baumann NA, Albert D, Attia ZI, Ladewig DJ, Yasin O, Dillon JJ, Singh B. Errors of Classification With Potassium Blood Testing: The Variability and Repeatability of Critical Clinical Tests. Mayo Clin Proc. 2018 May;93(5):566-572. doi: 10.1016/j.mayocp.2018.03.013.
- Derived from this study: PubMed 25415807Packham DK, Rasmussen HS, Lavin PT, El-Shahawy MA, Roger SD, Block G, Qunibi W, Pergola P, Singh B. Sodium zirconium cyclosilicate in hyperkalemia. N Engl J Med. 2015 Jan 15;372(3):222-31. doi: 10.1056/NEJMoa1411487. Epub 2014 Nov 21.
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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.
Henrik Rasmussen, MD study chair
ZS Pharma, Inc.
44 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zirconium silicate (acute phase) and Zirconium silicate (subacute phase) in people with Hyperkalemia, run by ZS Pharma, Inc. at 44 sites in 2 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 5 inclusion and 15 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 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Australia. 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. Some participants in this study may receive a placebo. 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 12 Oct 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?
Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. (time frame: Through 48 hours acute phase). The study lists 2 primary outcomes in all. 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 NCT01737697, which also lists 4 linked publications.
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 12 Oct 2018.