Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

PHASE3CompletedINTERVENTIONAL
Enrollment

754

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

November 30, 2013

Conditions
Hyperkalemia
Interventions
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.

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.

DRUG

Placebo (acute phase)

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

DRUG

Placebo ( subacute phase)

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

Trial Locations (44)

11206

Life Medi-Research and Management, Brooklyn

13903

United Medical Associates, Binghamton

18901

Doylestown Hospital Medical Research, Doylestown

20814

Washington Nephrology Associates, Bethesda

29118

South Carolina Nephrology & Hypertension, Orangeburg

29150

Carolina Diabetes and Kidney Center, Sumter

32123

Riverside Clinical Research, Edgewater

32168

PCCC of Volusia, New Smyrna Beach

32746

Endocrinology of Central Florida, Lake Mary

33015

San Marcus Research Clinic, Miami

33023

Prevention & Strengthening Solutions, Inc, Miramar

33125

Medical Consulting Center, Miami

33169

Elite Research Institute, Miami

33401

Metabolic Research Institute, West Palm Beach

33462

JEM Research Institute, Atlantis

33511

Clinical Research of Brandon, Brandon

33607

Clinical Research Trials of Florida, Tampa

33709

Meridien Research, St. Petersburg

33805

Meridien Research, Lakeland

34491

Lakeview Medical Research, Summerfield

34601

Meridien Research, Brooksville

35801

Saadat Ansari Internal Medicine, Huntsville

36207

Pinnacle Research Group, Anniston

39531

The Center for Clinical Trials, Biloxi

49007

Nephrology Center DBA, Paragon Health PC, Kalamazoo

60805

Research by Design, Evergreen Park

64111

Clinical Research Consultants, LLC, Kansas City

67213

Professional Research Network of Kansas, LLC, Wichita

77099

Southwest Houston Research, Ltd, Houston

78215

Clinical Advancement Center, PLLC, San Antonio

80230

Denver Nephrologists, PC, Denver

80909

Pikes Peak Nephrology Associates, Colorado Springs

84770

Southern Utah Kidney and Hypertension Center, St. George

85284

Southwest Clinical Research Institute, Tempe

85301

Aspire Clinical Studies, LLC, Glendale

90022

Academic Medical Research Institute, Los Angeles

90717

Torrance Clinical Research, Lomita

90723

Mohammad Ismail, Inc, Paramount

91910

California Institute of Renal Research, Chula Vista

92505

Apex Research of Riverside, Riverside

95825

Capital Nephrology Clinical Group, Sacramento

06762

Nephrology and Hypertension Associates, Middlebury

02250

Renal Research, Gosford

03073

Melbourne Renal Research Group, Reservoir

All Listed Sponsors
lead

ZS Pharma, Inc.

INDUSTRY

NCT01737697 - Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia | Biotech Hunter | Biotech Hunter