This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
Hyperphosphatemia, one of the most common complications of advanced chronic kidney disease, becomes increasingly prevalent as kidney function declines and is found almost universally in patients with end-stage kidney disease requiring dialysis. Hyperphosphatemia is an independent risk factor for cardiovascular outcomes, fractures, and mortality in patients with chronic kidney disease, especially in patients receiving dialysis. AP306 is a pan-phosphate transporter inhibitor that may stop phosphate absorption in the gut, controlling hyperphosphatemia. This is a randomized, double-blind, placebo-controlled, study to characterize the safety, tolerability, and efficacy of AP306 given daily for 8 weeks at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
168
AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
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)
Time frame: 8 weeks
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
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)
Time frame: 8 weeks
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AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.
Apogee Clinical Research, LLC
Huntsville, Alabama, United States
NOT_YET_RECRUITINGCalifornia Institute of Renal Research
Chula Vista, California, United States
NOT_YET_RECRUITINGAcademic Medical Research Institute
Los Angeles, California, United States
RECRUITINGColorado Kidney Care
Denver, Colorado, United States
RECRUITINGDaVita Clinical Research
Middlebury, Connecticut, United States
RECRUITINGUS Renal Care
Orange, Connecticut, United States
NOT_YET_RECRUITINGUS Renal Care
Fort Myers, Florida, United States
NOT_YET_RECRUITINGUS Renal Care
Dalton, Georgia, United States
NOT_YET_RECRUITINGSt. Clair Nephrology Research
Shelby, Michigan, United States
RECRUITINGJohnson County Clinical Trials
Kansas City, Missouri, United States
RECRUITING...and 16 more locations