Key Requirements: Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for clinical trials, but there may be additional requirements to qualify.
Participants Must:
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Have type 2 diabetes
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Be taking a consistent dose of 1 to 3 diabetes drugs by mouth for the last 3 months
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Be at high risk of heart or blood vessel diseases, or have kidney disease
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Have high blood sugar as measured by hemoglobin A1C (HbA1c at least 7%)
Participants Must Not:
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Have type 1 diabetes
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Have history of an inflamed pancreas (pancreatitis)
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Have history of an inflamed liver (hepatitis)
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Have used any weight loss drugs, including herbal or nutritional supplements, within the last 3 months
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AZ D9488C00001:The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant’s glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.
Participants Must:
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Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol
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Must be ≥ 18 years of age at the time of signing the informed consent.
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Must have eGFR ≥ 25 and ≤ 59 mL/min/1.73m2 as calculated by central laboratory (CKD-EPI formula) at screening (Visit 1)
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Must have UACR ≥ 200 and ≤ 5000 mg/g as calculated by central laboratory at screening (Visit 1). If the first sample does not fulfil eligibility criteria, a second sample can be obtained during the screening period; if so, the UACR measurement from the second sample must be within the eligibility range.
Participants Must Not:
- New York Heart Association class III to IV congestive heart failure at the time of screening (Visit 1) or previous history of severe or symptomatic heart failure.
- Myocardial infarction, unstable angina, stroke, or transient ischaemic attack within 3 months prior to screening (Visit 1).
- Participants with a known history of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg within 2 weeks prior to screening (Visit 1) are excluded. In addition, any participant with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg as measured at screening (Visit 1) and confirmed by repeated measurement is excluded. Participants may be rescreened once blood pressure is controlled.
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