A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Start Date
6/1/2026
Completion Date
3/31/2027
Summary
This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AP306 75 mg BID
AP306 125 mg BID
AP306 150 mg BID
AP306 75 mg TID
AP306 100 mg TID
AP306 125 mg TID
Placebo
Conditions
Locations
Apogee Clinical Research, LLC
Huntsville, Alabama 35801
United States
California Institute of Renal Research
Chula Vista, California 91910
United States
Academic Medical Research Institute
Los Angeles, California 90022
United States
North America Research Institute
San Dimas, California 91773
United States
Colorado Kidney Care
Denver, Colorado 80220
United States
DaVita Clinical Research
Middlebury, Connecticut 06762
United States
PACT Kidney Care
Orange, Connecticut 06477
United States
US Renal Care - Fort Myers South
Fort Myers, Florida 33912
United States
Nephrology & Hypertension Specialists
Dalton, Georgia 30720
United States
St. Clair Nephrology Research
Shelby, Michigan 48315
United States
DaVita Clinical Research Edina
Edina, Minnesota 55435
United States
Johnson County Clinical Trials
Kansas City, Missouri 64111
United States
DaVita Clinical Research
Las Vegas, Nevada 89107
United States
R1 Therapeutics Clinical Trial Site
Albuquerque, New Mexico 87109
United States
NY Kidney & Hypertension Medicine
Ridgewood, New York 11385
United States
US Renal Care - Alexis
Toledo, Ohio 43613
United States
Sunbeam Research
Greenville, Texas 75402
United States
DaVita Clinical Research
Houston, Texas 77054
United States
Gamma Medical Research
McAllen, Texas 78503
United States
US Renal Care - South San Antonio
San Antonio, Texas 35801
United States
US Renal Care - Westover Hills
San Antonio, Texas 78251
United States
DaVita Clinical Research San Antonio
San Antonio, Texas 78258
United States
US Renal Care
Waxahachie, Texas 75165
United States
DaVita Clinical Research Norfolk
Norfolk, Virginia 23502
United States
R1 Therapeutics Clinical Trial Site
Beijing, Beijing Municipality 100035
China
R1 Therapeutics Clinical Trial Site
Beijing, Beijing Municipality 100044
China
R1 Therapeutics Clinical Trial Site
Zhengzhou, Henan 450003
China
R1 Therapeutics Clinical Trial Site
Nanjing, Jiangsu 210003
China
R1 Therapeutics Clinical Trial Site
Nanjing, Jiangsu 210009
China
R1 Therapeutics Clinical Trial Site
Shanghai, Shanghai Municipality 201112
China
R1 Therapeutics Clinical Trial Site
Chengdu, Sichuan 610072
China