EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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 ( silicified microcrystalline cellulose) randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals.

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 (silicified microcrystalline cellulose)  randomized to mimic doses of experimental drug administered once a day (qd)  prior to the morning meal for 12 days.

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).

Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

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.

NCT ID

Therapeutic Area

Randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals for 48 hours during the acute phase.

Randomized to mimic doses of experimental drug administered once a day prior to the morning meal for 12 days during the subacute phase.

Riverside Clinical Research

South Carolina Nephrology & Hypertension

Lakeview Medical Research

Meridien Research

Elite Research Institute

Carolina Diabetes and Kidney Center

Pinnacle Research Group

Southwest Clinical Research Institute

Denver Nephrologists, PC

Professional Research Network of Kansas, LLC

Life Medi-Research and Management

Aspire Clinical Studies, LLC

United Medical Associates

Clinical Research Trials of Florida

Southern Utah Kidney and Hypertension Center

San Marcus Research Clinic

Torrance Clinical Research

The Center for Clinical Trials

Capital Nephrology Clinical Group

Washington Nephrology Associates

Southwest Houston Research, Ltd

Research by Design

Medical Consulting Center

Mohammad Ismail, Inc

Melbourne Renal Research Group

Renal Research

Prevention & Strengthening Solutions, Inc

Metabolic Research Institute

JEM Research Institute

Pikes Peak Nephrology Associates

Nephrology and Hypertension Associates

Nephrology Center DBA, Paragon Health PC

Apex Research of Riverside

Clinical Advancement Center, PLLC

Clinical Research Consultants, LLC

Doylestown Hospital Medical Research

Academic Medical Research Institute

Saadat Ansari Internal Medicine

California Institute of Renal Research

PCCC of Volusia

Endocrinology of Central Florida

Clinical Research of Brandon

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

To perform a controlled evaluation of the safety and efficacy of
four (4) different doses of ZS administered 3 times daily for 48
hours in the Acute Phase for patients with mild to moderate
hyperkalemia (potassium level between 5.0-6.5 mmol/l as
determined by i-STAT) at baseline.

Age, Customized

Sex/Gender, Customized. Gender by Acute Phase

Sex/Gender, Customized

Race/Ethnicity, Customized. Categories are not mutually exclusive

Race/Ethnicity, Customized

Acute S-K baseline

Study Specific Characteristic

Etiology of elevated S-K. Categories are not mutually exclusive

Etiology of elevated S-K

Acute phase baseline - estimated Glomerular filtration rate (eGFR)

Baseline eGFR

Subjects with non-missing acute phase baseline eGFR

One subject in ZS 5g group was randomized but was not treated and is excluded from baseline characatertics.

Through 24 Hours

Through 48 Hours

Difference  in the exponential rate of change in serum potassium (S-K) levels during the initial 48 hours of study drug treatment between the placebo-treated and ZS-treated subjects.

Through Day 8

Through Day 15

ITT population. One subject in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population

Difference in the exponential rate of change in S-K levels  in the subacute phase between those on subacute therapy and placebo

ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population

Time (median) to an increase in S-K values of 0.5 mmol/L (subacute phase)

Subjects from ITT population who have completed Acute phase

Percentage of Subjects who achieve normalization in S-K levels after 48 hours of treatment

Baseline, mean

Study Day 1: 1 hour Post 1st Dose

Study Day 1: 2 hour Post 1st Dose

Study Day 1: 4 hour Post 1st Dose

Study Day 2:
0 hour Pre-dose

Study Day 2: 1 hour Post 1st Dose

Study Day 2: 4 hour Post 1st Dose

Study Day 3: 0 hour Pre-dose

Mean change from baseline in S-K at all time points over initial 48 hours

Mean change from baseline in S-K at all time points acute phase

Study Day 1: 1 hour Post 1st Dose
Percent change

Study Day 1: 2 hour Post 1st Dose
Percent change

Study Day 1: 4 hour Post 1st Dose
Percent change

Study Day 2: 0 hour Pre-dose
Percent change

Study Day 2: 1 hour Post 1st Dose
Percent change

Study Day 2: 4 hour Post 1st Dose
Percent change

Study Day 3: 0 hour Pre-dose
Percent change

Mean percent change from baseline in S-K at all time points over initial 48 hours

Mean percent change from baseline in S-K change at all time points acute phase

Median time to normalization of S-K (as defined by S-K levels of 3.5 – 5.0
mmol/l) in acute phase

Time to normalization of S-K in acute phase

Median time to first decrease of 0.5 mmol/L in S-K levels in acute phase.

Time to first decrease of 0.5 mmol/L in S-K levels in acute phase

Time (number of days) subjects remain normokalemic (3.5 – 5.0 mmol/l) subacute phase

Time subjects remain
normokalemic (subacute phase)

Time (median) to relapse to S-K value (return to original S-K value)

Time (median) to relapse to S-K value

Proportion 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

Proportion of subjects within each
treatment group who retained normal S-K values at end of subacute phase

Acute Baseline,
mean

Subacute  Baseline, mean

Subacute Day  1

Subacute Day  2

Subacute Day 3

Subacute Day 6

Subacute Day 12

Subacute Day 18

Mean change from subacute baseline in serum potassium at all time points during subacute phase

Mean change from subacute baseline in serum potassium at all time points.

Subacute Day  1 Percent Change

Subacute Day  2 Percent  Change

Subacute Day 3 Percent  Change

Subacute Day  6 Percent  Change

Subacute Day  12 Percent  Change

Subacute Day  18 Percent  Change

Mean percent change from subacute baseline in serum potassium at all time points during subacute phase

Mean percent change from subacute baseline in serum potassium at all time points.

Acute Phase-Initial 48 hours

Subacute Phase

In the acute phase, 754 subjects were randomized; 753 were treated. Subjects who completed the AP and had i-STAT K+ values within normal range in a.m. of Study Day 3 could enter  the Subacute Phase. 543 subjects entered the subacute phase.

AstraZeneca Clinical Study Information Center

To perform a controlled evaluation of the safety and
efficacy of four different doses of ZS administered once
daily for 12 additional days in a subsequent Subacute
Phase for patients completing the Acute Phase and
achieving potassium levels within the normal range (3.5 -
4.9 mmol/l, as determined by i-STAT).

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