Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
This trial is active, not recruiting.
|Treatment||sodium zirconium cyclosilicate|
|Sponsor||ZS Pharma, Inc.|
|Start date||May 2014|
|End date||July 2015|
|Trial size||200 participants|
|Trial identifier||NCT02107092, ZS-004E|
Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E. Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|New Smyrna Beach, FL 32168||not available||no longer recruiting|
|Huntsville, AL 35801||not available||no longer recruiting|
|Scottsboro, AL 35768||not available||no longer recruiting|
|Phoenix, AZ 85027||not available||no longer recruiting|
|Tempe, AZ 85284||not available||no longer recruiting|
|Hawaiian Gardens, CA 90716||not available||no longer recruiting|
|Los Angeles, CA 90022||not available||no longer recruiting|
|Paramount, CA 90723||not available||no longer recruiting|
|Riverside, CA 92505||not available||no longer recruiting|
|Atlantis, FL 33462||not available||no longer recruiting|
|Bradenton, FL 34208||not available||no longer recruiting|
|Brandon, FL 33511||not available||no longer recruiting|
|Brooksville, FL 34601||not available||no longer recruiting|
|Deland, FL 32720||not available||no longer recruiting|
|Edgewater, FL 32132||not available||no longer recruiting|
|Miami, FL 33015||not available||no longer recruiting|
|Miami, FL 33125||not available||no longer recruiting|
|Miami Lakes, FL 33018||not available||no longer recruiting|
|Miami Lakes, FL 33014||not available||no longer recruiting|
|Somerset West, South Africa||not available||no longer recruiting|
|Ocala, FL 34471||not available||no longer recruiting|
|Summerfield, FL 34491||not available||no longer recruiting|
|Tampa, FL 33614||not available||no longer recruiting|
|Tampa, FL 33607||not available||no longer recruiting|
|Winter Park, FL 32789||not available||no longer recruiting|
|Columbus, GA 31901||not available||no longer recruiting|
|Decatur, GA 30030||not available||no longer recruiting|
|Evergreen Park, IL 60805||not available||no longer recruiting|
|Joliet, IL 60435||not available||no longer recruiting|
|Shrieveport, LA 71101||not available||no longer recruiting|
|Auburn, ME 04210||not available||no longer recruiting|
|Chesterfield, MI 48047||not available||no longer recruiting|
|Kansas City, MO 64411||not available||no longer recruiting|
|Las Vagas, NV 89115||not available||no longer recruiting|
|Flushing, NY 11355||not available||no longer recruiting|
|Altoona, PA 16602||not available||no longer recruiting|
|Providence, RI 02903||not available||no longer recruiting|
|Orangeburg, SC 29118||not available||no longer recruiting|
|Sumter, SC 29150||not available||no longer recruiting|
|Chattanooga, TN 37408||not available||no longer recruiting|
|San Antonio, TX 78229||not available||no longer recruiting|
|Gosford, Australia||not available||no longer recruiting|
|Woolloongabba, Australia||not available||no longer recruiting|
|Heidelberg, Australia||not available||no longer recruiting|
|Melbourne, Australia||not available||no longer recruiting|
|Parkville, Australia||not available||no longer recruiting|
|Meyerspark, South Africa||not available||no longer recruiting|
|Port Elizabeth, South Africa||not available||no longer recruiting|
|Anniston, AL 36207||not available||no longer recruiting|
|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 2 months.
Maintenance of serum potassium within normal range (3.5 5.0 mmol/l) with once daily ZS for 11 months after establishment of normokalemia in prior ZS-004 study, or after an additional 48-hour treatment with 10g ZS three times daily.
time frame: 11 months
Male or female participants at least 18 years old.
- Provision of written informed consent.
- Completed the ZS-004 DBRMP Study Day 29 visit or discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia and able to start dosing in ZS-004E within two (2) days after the last dose of Investigational product in ZS-004.
- Subject must have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive at the ZS-004 DBRMP Study Day 29 visit or a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive if the subject discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia .
- Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, history of severe leukocytosis or thrombocytosis.
- Subjects who received alternative treatment for hyperkalemia while participating in study ZS-004.
- Subjects with a life expectancy of less than 3 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 other than ZS 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.
|Official title||Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]|
|Description||All subjects with i-STAT potassium values between 3.5-5.5 mmol/l, inclusive at the ZS-004 DBRMP Study Day 29 visit, who continue directly into the open-label extension study ZS-004E, will enter the Maintenance Phase (MP) and start on open-label ZS at a dose of 10g qd. All subjects with i-STAT potassium values > 5.5 mmol/l at the ZS-004 DBRMP Study Day 29 visit will undergo an acute treatment phase (AP) where they will receive ZS 10g three times a day (tid) for 24 (3 doses) or 48 hours (6 doses). If the subject's i-STAT potassium is between 3.5-5.0 mmol/l, inclusive after 24 (AP Study Day 2) or 48 hours (AP Study Day 3), the subject will enter the MP at a starting dose of 10g qd. For subjects who discontinued during ZS-004 DBRMP due to hypo- or hyperkalemia baseline potassium values will be determined within 1 day of administration of the first dose in the ZS-004E extension study by taking two (2) consecutive i-STAT potassium measurements at 0 and 60 minutes (± 10 minutes). If the mean i-STAT value is between 3.5 - 5.5 mmol/l, inclusive, the subject will enter directly into the MP and receive 10g ZS qd; if the mean i-STAT potassium value is > 5.5 mmol/l, the subject will enter the AP. If i-STAT potassium values are still >5.0 mmol/l on the morning of AP Study Day 3, subjects will not enter the MP but will be referred to their normal health care provider for standard of care. If the i-STAT potassium value increases above 5.5 mmol/l during the MP with treatment at 10g qd, the dose can be increased to15g qd. Conversely, if S-K decreases to between 3.0-3.4 mmol/l, inclusive, the dose of ZS can be decreased in 5g qd, decrements. If a subject is on a 5g qd dose and still develops blood potassium i-STAT values between 3.0 - 3.4mmol, inclusive the dose can be reduced to 5g every other day. Subjects will receive up to 11 months of treatment with open-label ZS.|
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