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CompletedNCT01493024Updated Jun 29, 2018Results posted

Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia

A Phase 2 interventional study of Zirconium silicate (ZS) and Placebo in Hyperkalemia, Chronic Kidney Disease and Kidney Dysfunction, sponsored by ZS Pharma, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-29.

Sponsored by ZS Pharma, Inc. · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

It is hypothesized that zirconium silicate is safe and well tolerated and more effective than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and placebo (null hypothesis). It is hypothesized that zirconium silicate even up to the top dose of 10g three times a day is well tolerated.

Read the detailed description

A total of 90 subjects with moderate CKD (defined as GFR between 40- 60ml/min) and mild hyperkalemia (S-K between 5-6 mmol/l) will be enrolled in the study where, in a double-blind dose-escalating fashion (three separate cohorts), they will be randomized to receive one of the doses of ZS (0.3g, 3g and 10g) or placebo, administered 3 times (tid) daily with meals. The first cohort will have 18 subjects while both of the second and third cohorts will have 36 subjects for a total of 90 subjects.

Safety and tolerability will be assessed by an Independent Data Safety Monitoring Board (DSMB) after completion of each cohort, before escalation to the next dose level will be allowed. The next dose escalation will happen no sooner than one week after the last dose of study drug at the previous dosing level has been administered. Safety stopping rules will be specified for this study. Within the first dose level (300 mg dose), 12 subjects will be randomized to receive ZS, whereas 6 subjects will be randomized to receive placebo for a total of 18 subjects in this first cohort. In the next two cohorts (3 g and 10 g doses), 24 subjects per cohort will be randomized to receive ZS, whereas 12 subjects per cohort will be randomized to receive placebo for a total of 36 subjects in each of the second and third cohorts.

02

Conditions studied

  • Hyperkalemia
  • Chronic Kidney Disease
  • Kidney Dysfunction
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

ZS Pharma, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Provision of written informed consent.
  • Over 18 years of age.
  • GFR between 40-60 ml/min as estimated by the CKD-EPI equation. After screening two additional GFR values of between 40-60ml/min must be repeated within 24 hours before inclusion is allowed.
  • S-K between 5.0 - 6.0 mmol/l (inclusive) during Study Day 0.
  • Ability to have repeated blood draws or effective venous catheterization.
  • Women of child bearing potential must be practicing a highly effective method of birth control.

Exclusion criteria

Exclusion Criteria:

  • Pseudohyperkalemia such as excessive fist clinching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.
  • Subjects treated with lactulose, xifaxan or other non-absorbed antibiotics for hyperammonemia within the last 7 days.
  • Subjects treated with resins (such as sevelamer acetate, calcium acetate or calcium carbonate, lanthanum carbonate, Sodium polystyrene sulfonate (SPS; e.g. Kayexalate®) 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.
  • Women who are pregnant, lactating, or planning to become pregnant.
  • Subjects with Ketoacidosis/Acidemia.
  • Cancer within the last 5 years (other than successfully treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or early stage prostate cancer).
  • 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 Zirconium Silicate or to components thereof.
  • Subjects who have cardiac arrhythmias that require immediate treatment.
  • Subjects with ECG changes associated with hyperkalemia.
  • Subjects with acute kidney injury.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo (silicified microcrystalline cellulose) randomized to mimic escalating doses of experimental drug administered three times daily (TID) with meals.

    Drug: Placebo

  • Experimental
    Zirconium silicate (ZS)

    Randomized escalating doses (0.3g, 3g and 10g) of ZS (fractionated, protonated, microporous zirconium silicate, an oral sorbent) administered 3 times daily (tid) with meals.

    Drug: Zirconium silicate (ZS)

Interventions

  • DrugZirconium silicate (ZS)

    Randomized escalating doses (0.3g, 3g and 10g) of ZS (fractionated, protonated microporous Zirconium Silicate, an oral sorbent) administered 3 times daily (tid) with meals.

    Also known as: ZS-9

  • DrugPlacebo

    Randomized to mimic escalating doses of experimental drug administered 3 times daily (tid) with meals.

    Also known as: silicified microcrystalline cellulose

06

What researchers measure

Primary outcomes

  1. Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment

    The rate of fall in S-K levels during the initial 48 hours of study drug treatment between the placebo treated subjects and the ZS treated subjects measured on a log scale

    Time frame: 24 and 48 hours post first study drug dose

Secondary outcomes

  1. Serum Potassium (S-K) at Individual Time Points.

    Serum potassium (S-K) at individual time points through Study day 3/0hour.

    Time frame: First 48 hours of study

  2. Time Specific S-K Levels to Normalization

    Percent of subjects achieving S-K normalization (\<=as defined by S-K levels of 3.5 to 4.9 mmol/L) from baseline at Study Days 2 and 3 at 0 hr.

    Time frame: 48 and 72 hours post first study drug dose

  3. Time Specific Decreases in S-K Levels of > = 0.5 mmol/L

    Percentage of participants achieving a 0.5mmol/L drop from baseline at Study Days 2 and 3 at 0 hr.

    Time frame: 24 and 48 hours post first study drug dose

  4. Percentage of Participants With Normal S-K Levels at End of Study Day 2

    Percentage (%) of subjects who achieve S-K normalization at end of Study Day 2

    Time frame: 48 hours post first study drug dose

  5. Urine Sodium Excretion

    Urine sodium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).

    Time frame: 24 and 48 hours post first study drug dose

  6. Urine Potassium Excretion

    Urine potassium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).

    Time frame: 24 and 48 hours post study drug dose

  7. Urea Nitrogen Excretion

    Urea nitrogen excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).

    Time frame: 24 and 48 hours post study drug dose

  8. Blood Urea Nitrogen

    Blood urea nitrogen compared between the combined placebo-treated controls and the ZS-treated subjects (measured 24 \& 48 hours post dose on Study Days 2 and 3).

    Time frame: 24 and 48 hours post study drug dose

  9. Serum Magnesium (S-Mg) Levels

    Serum magnesium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

    Time frame: 24 and 48 hours post study drug dose

  10. Serum Calcium (S-Ca) Levels

    Serum calcium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

    Time frame: 24 and 48 hours post study drug dose

  11. Serum Sodium (S-Na) Levels

    Serum sodium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

    Time frame: 24 and 48 hours post study drug dose

  12. Serum Bicarbonate (HCO3) Levels

    Serum bicarbonate compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

    Time frame: 24 and 48 hours post study drug dose

  13. 24-hour Urinary Excretion of Potassium

    24-hour urinary excretion of potassium on Study Days 1 and Day 2

    Time frame: 24 and 48 hours post study drug dose

  14. 24-hour Urinary Excretion of Sodium

    24-hour urinary excretion of sodium on Study Days 1 and Day 2

    Time frame: 48 hours

  15. 24-hour Urinary Excretion of Urea Nitrogen

    24-hour urinary excretion of urea nitrogen on Study Days 1 and Day 2

    Time frame: 48 hours

  16. 24-hour Urinary Excretion of Creatinine

    24-hour urinary excretion of creatinine on Study Days 1 and Day 2

    Time frame: 48 hours

07

Results

Posted Jun 29, 2018

Participant flow

Participants took part in the study at 9 centers in the United States from 28 November 2011 to 22 May 2012.

Participant flow — Overall Study
MilestonePlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Started30122424
Completed30122424
Not completed0000

Outcome measures

PrimaryDifference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment

The rate of fall in S-K levels during the initial 48 hours of study drug treatment between the placebo treated subjects and the ZS treated subjects measured on a log scale

Time frame:
24 and 48 hours post first study drug dose
Reported as:
Mean · log(mmol/L/hour)
Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment
log(mmol/L/hour)Placebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Day2/0 Hr ( 24 hours)0 ± NA-0.00035 ± 0.001166-0.00169 ± 0.000932-0.000143 ± 0.000932
Day 3/0 Hr (48 hours)0 ± NA-0.00045 ± 0.000555-0.00089 ± 0.000444-0.00256 ± 0.000444
SecondarySerum Potassium (S-K) at Individual Time Points.

Serum potassium (S-K) at individual time points through Study day 3/0hour.

Time frame:
First 48 hours of study
Reported as:
Mean · mmol/L
Serum Potassium (S-K) at Individual Time Points.
mmol/LPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline5.14 ± 0.3585.22 ± 0.2645.02 ± 0.3225.05 ± 0.359
Day 1/4Hr Post 1st Dose4.97 ± 0.5645.06 ± 0.4174.93 ± 0.5184.80 ± 0.466
Day 1/4Hr Post 2nd Dose4.91 ± 0.4655.14 ± 0.6094.80 ± 0.5434.68 ± 0.420
Day 1/4Hr Post 3rd Dose4.82 ± 0.5584.91 ± 0.3684.68 ± 0.5774.50 ± 0.397
Day 2/0Hr4.97 ± 0.5214.90 ± 0.4474.66 ± 0.4344.73 ± 0.463
Day 2/4Hr Post 1st Dose5.03 ± 0.4414.97 ± 0.3634.81 ± 0.6014.53 ± 0.411
Day 2/4Hr Post 2nd Dose5.02 ± 0.4265.04 ± 0.4174.72 ± 0.6044.43 ± 0.460
Day 2/4Hr Post 3rd Dose4.87 ± 0.4864.83 ± 0.5264.60 ± 0.5664.13 ± 0.388
Day 3/0Hr4.94 ± 0.5494.92 ± 0.5064.68 ± 0.4914.37 ± 0.448
Day 1/30 Min Post 1st Dose5.17 ± 0.4195.25 ± 0.4765.09 ± 0.6245.03 ± 0.456
Day 1/1 Hour Post 1st Dose5.26 ± 0.5245.23 ± 0.5355.03 ± 0.5654.94 ± 0.438
Day 1/2 Hour Post 1st Dose5.12 ± 0.5325.35 ± 0.5055.05 ± 0.6674.93 ± 0.429
Day 2/20Hr Post 1st Dose4.8 ± 0.4384.83 ± 0.5554.60 ± 0.5804.19 ± 0.378
SecondaryTime Specific S-K Levels to Normalization

Percent of subjects achieving S-K normalization (\<=as defined by S-K levels of 3.5 to 4.9 mmol/L) from baseline at Study Days 2 and 3 at 0 hr.

Time frame:
48 and 72 hours post first study drug dose
Reported as:
Number · percentage of participants
Time Specific S-K Levels to Normalization
percentage of participantsPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Day2/0Hr907595.8100
Day 3/0Hr9010095.8100
SecondaryTime Specific Decreases in S-K Levels of > = 0.5 mmol/L

Percentage of participants achieving a 0.5mmol/L drop from baseline at Study Days 2 and 3 at 0 hr.

Time frame:
24 and 48 hours post first study drug dose
Reported as:
Number · percentage of participants
Time Specific Decreases in S-K Levels of > = 0.5 mmol/L
percentage of participantsPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Day 2/0Hr16.733.337.533.3
Day 3/0Hr26.741.741.762.5
SecondaryPercentage of Participants With Normal S-K Levels at End of Study Day 2

Percentage (%) of subjects who achieve S-K normalization at end of Study Day 2

Time frame:
48 hours post first study drug dose
Reported as:
Number · percentage of participants
Percentage of Participants With Normal S-K Levels at End of Study Day 2
percentage of participantsPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Percentage of Participants With Normal S-K Levels at End of Study Day 2907595.8100
SecondaryUrine Sodium Excretion

Urine sodium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).

Time frame:
24 and 48 hours post first study drug dose
Reported as:
Mean · mmol/L
Urine Sodium Excretion
mmol/LPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline91.5 ± 30.3173.5 ± 29.7981.7 ± 33.1674.5 ± 34.20
Day 1/0-24Hr74.4 ± 24.866.7 ± 18.4966.8 ± 26.2667.1 ± 29.19
Day 2/24-48Hr80.1 ± 28.2167.5 ± 26.6371.6 ± 31.6175.8 ± 35.74
SecondaryUrine Potassium Excretion

Urine potassium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mmol/L
Urine Potassium Excretion
mmol/LPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline36.6 ± 12.4732.2 ± 2.1238.3 ± 11.8230.3 ± 15.81
Day1/0-24Hr28.7 ± 6.4132.0 ± 3.1630.6 ± 5.9619.7 ± 9.69
Day2/24-48Hr29.2 ± 6.4231.0 ± 0.0030.5 ± 6.5116.9 ± 8.80
SecondaryUrea Nitrogen Excretion

Urea nitrogen excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mg/dL
Urea Nitrogen Excretion
mg/dLPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline525.0 ± 219.79430.2 ± 162.92481.0 ± 198.92424.7 ± 171.88
Day1/ 0-24 HR389.2 ± 179.91401.8 ± 265.74414.1 ± 177.54368.5 ± 147.37
Day2/ 24-48 HR460.9 ± 175.09337.6 ± 115.06477.0 ± 157.04416.6 ± 219.56
SecondaryBlood Urea Nitrogen

Blood urea nitrogen compared between the combined placebo-treated controls and the ZS-treated subjects (measured 24 \& 48 hours post dose on Study Days 2 and 3).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mg/dL
Blood Urea Nitrogen
mg/dLPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline24.50 ± 7.48123.52 ± 8.21725.16 ± 8.06530.37 ± 8.092
Day 2/)0Hr24.05 ± 7.62623.63 ± 7.24123.98 ± 7.61927.53 ± 7.602
Day 3/0Hr24.50 ± 7.28423.33 ± 7.89524.04 ± 7.66125.60 ± 7.942
SecondarySerum Magnesium (S-Mg) Levels

Serum magnesium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mg/dL
Serum Magnesium (S-Mg) Levels
mg/dLPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline1.93 ± 0.2581.95 ± 0.3271.93 ± 0.1431.85 ± 0.235
Day 2/0Hr1.92 ± 0.1971.93 ± 0.2711.94 ± 0.1821.81 ± 0.225
Day 3/0Hr1.90 ± 0.2041.89 ± 0.2571.94 ± 0.1791.83 ± 0.218
SecondarySerum Calcium (S-Ca) Levels

Serum calcium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mg/dL
Serum Calcium (S-Ca) Levels
mg/dLPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline9.46 ± 0.5959.37 ± 0.3419.48 ± 0.3379.50 ± 0.469
Day 2/0 Hr9.39 ± 0.4399.36 ± 0.5079.33 ± 0.3889.22 ± 0.466
Day 3/0 hr9.51 ± 0.5449.33 ± 0.3609.30 ± 0.3979.05 ± 0.425
SecondarySerum Sodium (S-Na) Levels

Serum sodium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mmol/L
Serum Sodium (S-Na) Levels
mmol/LPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline139.4 ± 2.84139.1 ± 3.65140.0 ± 3.09137.7 ± 3.45
Day 2/0 hr140.1 ± 3.24138.8 ± 2.04140.1 ± 3.83138.6 ± 3.37
Day 3/0 hr140.0 ± 3.36138.5 ± 2.28140.0 ± 3.91139.6 ± 3.50
SecondarySerum Bicarbonate (HCO3) Levels

Serum bicarbonate compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 \& 48 hours post dose on Study Days 2 and 3).

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mmol/L
Serum Bicarbonate (HCO3) Levels
mmol/LPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailyZirconium Silicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline28.1 ± 2.9928.6 ± 3.1128.1 ± 3.2627.4 ± 3.58
Day 2/0 hr28.6 ± 2.4629.2 ± 3.5128.3 ± 3.1530.1 ± 1.79
Day 3/0 hr29.0 ± 3.6628.3 ± 2.9628.7 ± 3.2530.1 ± 2.31
Secondary24-hour Urinary Excretion of Potassium

24-hour urinary excretion of potassium on Study Days 1 and Day 2

Time frame:
24 and 48 hours post study drug dose
Reported as:
Mean · mmol/24 hour
24-hour Urinary Excretion of Potassium
mmol/24 hourPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailyZirconium Silicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline56.5 ± 33.9662.4 ± 31.5158.9 ± 20.4446.9 ± 23.67
Study Day 164.7 ± 28.0289.4 ± 46.6260.5 ± 25.4241.0 ± 20.49
Study Day 265.4 ± 29.2386.6 ± 52.6458.1 ± 24.7731.1 ± 16.55
Secondary24-hour Urinary Excretion of Sodium

24-hour urinary excretion of sodium on Study Days 1 and Day 2

Time frame:
48 hours
Reported as:
Mean · mmol/24 hour
24-hour Urinary Excretion of Sodium
mmol/24 hourPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailyZirconium Silicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline145 ± 93.05132.8 ± 51.09124.0 ± 46.24114.8 ± 49.0
Study Day 1169.4 ± 88.90173.7 ± 64.02136.6 ± 79.5141.0 ± 68.05
Study Day 2181.8 ± 101.42181.5 ± 101.63132.5 ± 63.06140.2 ± 66.86
Secondary24-hour Urinary Excretion of Urea Nitrogen

24-hour urinary excretion of urea nitrogen on Study Days 1 and Day 2

Time frame:
48 hours
Reported as:
Mean · g/24 hour
24-hour Urinary Excretion of Urea Nitrogen
g/24 hourPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailyZirconium Silicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline7.66 ± 3.6227.59 ± 2.7687.03 ± 2.6796.74 ± 2.618
Day 18.30 ± 3.8328.51 ± 5.5497.99 ± 3.9297.80 ± 3.460
Day 210.37 ± 6.5858.68 ± 2.4758.57 ± 3.4537.49 ± 3.077
Secondary24-hour Urinary Excretion of Creatinine

24-hour urinary excretion of creatinine on Study Days 1 and Day 2

Time frame:
48 hours
Reported as:
Mean · mg/24 hour
24-hour Urinary Excretion of Creatinine
mg/24 hourPlacebo (Combined All Three Cohorts)Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
Baseline1175.39 ± 482.7081149.00 ± 483.7401126.26 ± 446.7451015.67 ± 471.275
Day 11157.12 ± 506.5151027.50 ± 301.315996.45 ± 442.3331008.25 ± 428.524
Day 21270.71 ± 544.5961092.23 ± 411.4691050.29 ± 344.8821028.79 ± 430.408

Adverse events

Collected over Study Days 1 to 7. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/30 (0%)0/30 (0%)3/30 (10%)
Sodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times Daily0/12 (0%)0/12 (0%)1/12 (8.3%)
Sodium Zirconium Cyclosilicate 3 g Three Times Daily0/24 (0%)0/24 (0%)3/24 (12.5%)
Sodium Zirconium Cyclosilicate 10 g Three Times Daily0/24 (0%)0/24 (0%)8/24 (33.3%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times Daily
VomitingGastrointestinal disorders1/300/120/243/24
DiarrheaGastrointestinal disorders0/301/120/241/24
NauseaGastrointestinal disorders1/300/121/242/24
Abdominal painGastrointestinal disorders0/301/120/240/24
Urinary tract infectionInfections and infestations0/300/121/242/24
HypertensionVascular disorders0/300/120/241/24
ConstipationGastrointestinal disorders0/300/121/240/24
DyspepsiaGastrointestinal disorders0/300/120/241/24
Aspartate aminotransferae increasedInvestigations0/300/121/240/24
Pain in extremityMusculoskeletal and connective tissue disorders0/300/120/241/24

Baseline characteristics

Age, Continuous
Age, Continuous(Years)PlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times DailyTotal
Mean69.7 ± 11.070.3 ± 6.972.0 ± 6.372.3 ± 11.771.1 ± 9.59
Sex/Gender, Customized
Sex/Gender, Customized(Participants)PlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times DailyTotal
Female76101538
Male23614952
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times DailyTotal
White2912242388
Black or African American10001
American Indian or Alaska Native00011
Serum potassium
Serum potassium(mmol/L)PlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times DailyTotal
Mean5.19 ± 0.3015.25 ± 0.1445.11 ± 0.3285.13 ± 0.3785.16 ± 0.314
Weight at baseline
Weight at baseline(kilograms)PlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times DailyTotal
Mean95.15 ± 22.12284.76 ± 18.02288.96 ± 22.00286.59 ± 26.31189.83 ± 22.794
GFR at Study Day 0
GFR at Study Day 0(mL/min/1.73 m^2)PlaceboSodium Zirconium Cyclosilicate (ZS) 0.3 g Three Times DailySodium Zirconium Cyclosilicate 3 g Three Times DailySodium Zirconium Cyclosilicate 10 g Three Times DailyTotal
Mean45.6 ± 9.0546.2 ± 4.9946.8 ± 7.1443.5 ± 9.0145.4 ± 8.09
08

Study locations

9 sites
  • Southwest Clinical Research Institute
    Tempe, Arizona 85284, United States
  • West Coast Clinical Trials
    Costa Mesa, California 92626, United States
  • Riverside Clinical Research
    Edgewater, Florida 32132, United States
  • Elite Research Institute, Inc.
    Miami, Florida 33169, United States
  • Compass Research Phase 1, LLC
    Orlando, Florida 32806, United States
  • Lakeview Medical Research
    Summerfield, Florida 34491, United States
  • Johnson County Clin-Trials
    Lenexa, Kansas 66219, United States
  • Southwest Houston Research, Ltd
    Houston, Texas 77099, United States
  • Renal Associates, P.A.
    San Antonio, Texas 78215, United States
09

References and documents

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 32588430 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01493024
Lead sponsor
ZS Pharma, Inc.
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Nov 30, 2011
Primary completion
May 31, 2012
Completion
Jun 30, 2012
Results posted
Jun 29, 2018
Last update
Jun 29, 2018

Study contacts

Henrik Rasmussen, MD
study chair · ZS Pharma, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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