Overview

Principal investigator

Hanna Zembrzuska
Internal Medicine

Eligibility criteria

Key Inclusion Criteria:
*  Provision of signed and dated ICF
*  Age ≥ 12 years when signing the ICF
*  Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
*  For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
*  Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is: 1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL) 2. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)

Key Exclusion Criteria:
*  History or plan of kidney transplantation
*  History or plan of parathyroid intervention 6 months before signing the ICF
*  Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
*  Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
*  Presence of clinically significant gastrointestinal (GI) disorder
*  History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
*  Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
*  Female who are breastfeeding
Show more

Participate in this trial

Are you interested in enrolling in this study? Learn more here.

I'm Interested In Participating

For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Ashley Pieper
Enroll your patient