A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia

Launched by ALEBUND PHARMACEUTICALS · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AP306 to see if it can help lower high blood phosphate levels in patients with chronic kidney disease who are undergoing regular hemodialysis. Phosphate is a mineral that can build up in the blood when the kidneys aren't working well, and high levels can lead to serious health issues. The trial will compare AP306 to a placebo, which is a look-alike pill that has no active medication, to understand if AP306 is effective and what side effects, if any, it may cause.

To participate in this trial, individuals must be between the ages of 65 and 74 and currently on a stable hemodialysis regimen for at least 12 weeks. They should be willing to stop any medications they are taking for lowering phosphate levels and will need to take either AP306 or the placebo three times a day for 12 weeks. Participants will be closely monitored to ensure that their phosphate levels remain within a specific range. It’s important to note that certain medical conditions or treatments may exclude someone from participating, so potential volunteers should discuss their health history with the study team.

Gender

ALL

Eligibility criteria

• Important Inclusion Criteria:
• • 1. Who signes a written informed consent form (ICF) and is willing to comply with all study requirements in the study
• • 2. Who is receiving a stable hemodialysis regimen, which is defined as a frequency of three times per week for at least 12 weeks before the ICF sign off, and doesn't plan to change in the study
• • 3. Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening
• • 4. If the participant is receiving any of the following therapies, their doses are stable for at least 4 weeks before the ICF sign off visit: phosphate-lowering products other than phosphate binders, active vitamin D and analogs or nutritional vitamin D, calcimimetics, calcitonin, and P-glycoprotein inhibitors or inducers
• • 5. Who has a blood phosphate level within the study-required range
• Important Exclusion Criteria:
• • 1. Pregnant or breastfeeding
• • 2. Scheduled for a living donor kidney transplant in the next 6 months, planned change to peritoneal dialysis or home hemodialysis in the study; planned relocation to another dialysis center in the study
• • 3. Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study
• • 4. Uncontrolled blood calcium abnormality
• • 5. Uncontrolled blood intact parathyroid hormone abnormality
• • 6. Hemoglobin \<9 mg/dL (90 g/L)
• • 7. Acute hepatitis or significant chronic liver disease
• • 8. Any clinically significant GI disorders within 4 weeks prior to the ICF sign off; or any history of gastrectomy; or any GI tract surgery, excluding appendectomy and polypectomy, within 12 weeks prior to the ICF sign off
• • 9. Uncontrolled hypertension
• • 10. Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to the ICF sign off
• • 11. Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test
• • 12. Any active infection or infestation or any treatment with antibiotics within 2 weeks prior to the ICF sign off
• • 13. History or presence of malignancy within 3 years prior to the ICF sign off, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer
• • 14. Concomitant use of moderate or strong cytochrome P450 (CYP) 3A inhibitors or inducers within 2 weeks or 5 half-lives, whichever is longer, prior to the ICF sign off (topical use is allowed)
• • 15. Treatment with any investigational medication or medical device within 30 days prior to the ICF sign off