Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
This trial has been completed.
|Treatment||sodium zirconium cyclosilicate|
|Sponsor||ZS Pharma, Inc.|
|Start date||June 2014|
|End date||November 2016|
|Trial size||751 participants|
|Trial identifier||NCT02163499, ZS-005|
The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsboro, AL 35768||not available||completed|
|Tempe, AZ 85284||not available||completed|
|Tucson, AZ 85724||not available||completed|
|Chula Vista, CA 90717||not available||completed|
|Los Angeles, CA 90022||not available||completed|
|Paramount, CA 90723||not available||completed|
|Riverside, CA 92505||not available||completed|
|Sacramento, CA 95825||not available||completed|
|Whittier, CA 90603||not available||completed|
|Denver, CO 80230||not available||completed|
|Brandon, FL 33511||not available||completed|
|Deland, FL 32720||not available||completed|
|Hudson, FL 34667||not available||completed|
|Lauderlale Lakes, FL 33313||not available||completed|
|Miami Lakes, FL 33018||not available||completed|
|Miami, FL 33015||not available||completed|
|Miami, FL 33125||not available||completed|
|New Smyrna Beach, FL 32168||not available||completed|
|New Smyrna, FL 32168||not available||completed|
|Tampa, FL 33614||not available||completed|
|Winter Park, FL 32789||not available||completed|
|Columbus, GA 31901||not available||completed|
|Evergreen Park, IL 60805||not available||completed|
|Joliet, IL 60435||not available||completed|
|Paducah, KY 42003||not available||completed|
|Shreveport, LA 71101||not available||completed|
|Chesterfield, MI 48047||not available||completed|
|Kansas City, MO 64411||not available||completed|
|St Louis, MO 63110||not available||completed|
|Great Neck, NY 11021||not available||completed|
|Providence, RI 02903||not available||completed|
|Orangeburg, SC 29118||not available||completed|
|Sumter, SC 29150||not available||completed|
|Chattanooga, TN 37408||not available||completed|
|San Antonio, TX 78215||not available||completed|
|San Antonio, TX 78229||not available||completed|
|St. George, UT 84770||not available||completed|
|Gosford, Australia 2250||not available||completed|
|Woolloongabba, Australia 4102||not available||completed|
|Heidelberg, Australia 3084||not available||completed|
|Melbourne, Australia 3073||not available||completed|
|Parkville, Australia 3050||not available||completed|
|Berlin, Germany 13353||not available||completed|
|Stuttgart, Germany 70376||not available||completed|
|Amsterdam, Netherlands 1105 AZ||not available||completed|
|Lasi, Romania 700503||not available||completed|
|Cape Town, South Africa 7925||not available||completed|
|Meyerspark, South Africa||not available||completed|
|Port Elizabeth, South Africa 6001||not available||completed|
|Somerset West, South Africa 7130||not available||completed|
|Leicester, United Kingdom LE1 9HN||not available||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
Open label oral administration of sodium zirconium cyclosilicate 10g once daily for up to 12 months.
Safety and Tolerability of long-term dosing with ZS.
time frame: Up to 12 months
The proportion of subjects who can maintain normokalemia.
time frame: Up to 12 months
Male or female participants at least 18 years old.
- Provision of written informed consent.
- Over 18 years of age.
- Two consecutive i STAT potassium values, measured 60 (+/- 15) minutes apart, both >/= 5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.
- Ability to have repeated blood draws or effective venous catheterization.
- Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test at Acute Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Controlled diabetic subjects.
- Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
- Subjects treated with lactulose, rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.
- Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium polystyrene sulfonate (eg, Resonium®) within 3 days prior to first dose of ZS on Acute Phase Study Day 1.
- Subjects with a life expectancy of less than 12 months.
- 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 diabetic ketoacidosis.
- 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 ZS or to components thereof.
- Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
- Subjects with cardiac arrhythmias that require immediate treatment.
- Subjects on dialysis.
- Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
- Documented GFR <15 mL/min within 90 days prior to study entry.
|Official title||Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia|
|Description||Subjects with 2 consecutive i STAT potassium values 5.1 mmol/L will enter the Acute Phase and receive ZS 10 g tid for 24 to 72 hours, depending on potassium values. Once normokalemia (i STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be enrolled in the Maintenance Phase to be dosed with ZS at a starting dose of 10 g qd. Potassium (i STAT and central laboratory) will be measured weekly throughout the first month of study and every 4 weeks thereafter through Month 12. During the Maintenance Phase, the ZS dose may be increased or decreased in increments/decrements of 5 g qd up to a maximum of 15 g qd or a minimum of 5 g every other day based on i STAT potassium measurements as outlined below: - > 5.5 mmol/L: increase ZS dose to 15 g qd (if the 10 g dose was well tolerated) - Between 3.0 and 3.4 mmol/L, inclusive: decrease ZS dose in 5 g qd decrements to a minimum dose of 5 g every other day; if a subject's i STAT potassium value remains between 3.0 and 3.4 mmol/L, inclusive, on the ZS 5 g every other day dose, the subject will be withdrawn from the study and receive standard of care treatment. There is no limit to the number of dose titrations allowed. Subjects will receive up to 12 months of treatment with open-label ZS.|
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