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

Study identifier:ZS-002

ClinicalTrials.gov identifier:NCT01493024

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Multicenter, Prospective, Randomized, Placebo-Controlled, Double-blind Dose Escalating Study of Safety, Tolerability and Pharmacodynamics of Zirconium Silicate in Chronic Kidney Disease and Moderate Kidney Dysfunction with Mild Hyperkalemia

Medical condition

Hyperkalemia

Phase

Phase 2

Healthy volunteers

Study drug

Zirconium silicate (ZS), Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 30 Nov 2011

Primary Completion Date: 31 May 2012

Study Completion Date: 30 Jun 2012

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Supportive Care

Verification:

Verified 01 May 2018 by ZS Pharma, Inc.

Collaborators

Inclusion and exclusion criteria

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

- 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.

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo (silicified microcrystalline cellulose) randomized to mimic escalating doses of experimental drug administered three times daily (TID) with meals.	Drug: Placebo Randomized to mimic escalating doses of experimental drug administered 3 times daily (tid) with meals. Other Name: silicified microcrystalline cellulose
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) 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. Other Name: ZS-9

Documents available

Trial Results Summaries
Available here

Contacts

Investigators

Principal Investigator

Henrik Rasmussen

ZS Pharma, Inc