A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients

Launched by ALEBUND PHARMACEUTICALS · Mar 9, 2023

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Eligibility criteria

• Important Inclusion Criteria:
• • 1. On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
• • 2. Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
• • 3. Serum phosphorus within the trial-required range
• Important Exclusion Criteria:
• • 1. Pregnant or breastfeeding
• • 2. Any history of kidney transplant
• • 3. Any history of a parathyroid intervention
• • 4. Any clinically significant GI disorders within 4 weeks prior to the screening visit
• • 5. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
• • 6. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
• • 7. Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate