This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study
Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study
Who has a blood phosphate level within the study-required range
Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening or any documented value ≥1.20 within 12 weeks prior to signing the ICF
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
Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study
Blood calcium or blood intact parathyroid hormone abnormality
Parallel
AP306 75 mg BID
DrugAP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 125 mg BID
DrugAP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 150 mg BID
DrugAP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 75 mg TID
DrugAP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
AP306 100 mg TID
DrugAP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
AP306 125 mg TID
DrugAP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
Placebo
DrugPlacebo given by mouth, three times daily. Treatment given daily for 8 weeks.
7
Treatment groupsSee each treatment group below.
To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis
The change in serum phosphate from baseline to the end of treatment or before the initiation of rescue therapy, or before the interruption of study drug due to serum phosphate \<2.5 mg/dL (0.81 mmol/L)
To assess the proportion of participants with serum phosphate in the target range
Achievement of serum phosphate concentrations within the target range (between 3.5 and 5.5 mg/dL \[1.13 and 1.78 mmol/L\], inclusive) at any time during the Treatment Period
To assess the change in serum phosphate from baseline to the end of the Treatment Period
The change in serum phosphate from baseline to the end of Treatment Week 8.
To assess the time to response on serum phosphate reduction
* The change in serum phosphate over time * The time to the first occurrence of serum phosphate ≤5.5 mg/dL (1.78 mmol/L) and ≤4.5 mg/dL (1.45 mmol/L)
To evaluate the pharmacokinetic (PK) characteristics of AP306
* The plasma concentration of AP306 at the following time points: baseline, after 4 weeks of treatment, and after 8 weeks of treatment * The constituent and proportion of metabolites at PK sampling time points
To evaluate the overall safety and tolerability of AP306
* The nature, frequency, and severity of all treatment emergent and serious adverse events (AEs) * The effects on laboratory values, vital signs, electrocardiogram (ECG) parameters, and Bristol Stool Form Scale
To assess the effects of AP306 on intact parathyroid hormone (iPTH) and fibroblast growth factor (FGF23) concentration
The change in iPTH and FGF23 from the baseline to the end of Treatment Week 8 (or early termination (ET) visit for those who terminate study drug), and the end of the study
Click on the lead sponsor to view all of their trials.
R1 Therapeutics
Lead sponsor
Alebund Pharmaceuticals
Collaborator
