A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hy… (NCT06712654) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia
144 participantsStarted 2025-04-10
Plain-language summary
The goal of this clinical trial is to learn if AP306 could work in the patients receiving maintenance hemodialysis with elevated blood phosphate. The main questions it aims to answer are:
* Does AP306 lower blood phosphate levels when the participants take a fixed dose of AP306?
* What medical problems do the participants have when taking AP306?
The researchers will compare AP306 to a placebo (a look-alike substance that contains no drug) to see if AP306 works to treat hyperphosphatemia.
The participants will:
* Stop all using blood phosphate-lowering drugs, and
* Take AP306 or a placebo three times a day for 12 weeks.
If the participant has a blood phosphate level above a certain level, they will receive additional treatment to lower the blood phosphate level.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Who signes a written informed consent form (ICF) and is willing to comply with all study requirements in the study
✓. 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
✓. Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening
✓. 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
✓. Who has a blood phosphate level within the study-required range
Exclusion criteria
✕. Pregnant or breastfeeding
✕. 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
What they're measuring
1
To evaluate the efficacy of AP306 assessed by serum phosphate lowering
✕. Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study
✕. Acute hepatitis or significant chronic liver disease
✕. 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