Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01493024
Study type	Interventional
Source	ZS Pharma, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	November 30, 2011
Completion date	June 30, 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated	`NCT04043026` - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed	`NCT05318014` - Low-protein Formula Supplements in Chronic Kidney Disease	N/A
Active, not recruiting	`NCT06071065` - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients	N/A
Completed	`NCT02878317` - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting	`NCT06039254` - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function	Phase 1
Recruiting	`NCT03160326` - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT02756520` - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed	`NCT02896309` - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity	N/A
Completed	`NCT02875886` - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease	Phase 4
Withdrawn	`NCT02885545` - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial	Phase 4
Completed	`NCT02836574` - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease	Phase 2
Active, not recruiting	`NCT02483039` - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization	N/A
Completed	`NCT02992548` - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease	Phase 4
Terminated	`NCT02543177` - Optimised Procedure in Patients With NSTEMI and CKD	N/A
Completed	`NCT02369549` - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease	Phase 3
Recruiting	`NCT02205944` - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes	N/A
Active, not recruiting	`NCT02231138` - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms