Status:
COMPLETED
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia
Lead Sponsor:
ZS Pharma, Inc.
Conditions:
Hyperkalemia
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 betwe...
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 fas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01493024
Start Date
November 30 2011
End Date
June 30 2012
Last Update
June 29 2018
Active Locations (9)
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1
Southwest Clinical Research Institute
Tempe, Arizona, United States, 85284
2
West Coast Clinical Trials
Costa Mesa, California, United States, 92626
3
Riverside Clinical Research
Edgewater, Florida, United States, 32132
4
Elite Research Institute, Inc.
Miami, Florida, United States, 33169