A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Condition(s) studied
Investigational drug(s) / intervention(s)
AP306 75 mg BID: AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 125 mg BID: AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 150 mg BID: AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 75 mg TID: AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
AP306 100 mg TID: AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
AP306 125 mg TID: AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
Placebo: Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.
Study 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.
Eligibility
Primary outcome measure(s)
- To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis — 8 weeks
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)
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Apogee Clinical Research, LLC | Huntsville | Alabama | Recruiting |
| California Institute of Renal Research | Chula Vista | California | Recruiting |
| Academic Medical Research Institute | Los Angeles | California | Recruiting |
| North America Research Institute | San Dimas | California | Recruiting |
| Colorado Kidney Care | Denver | Colorado | Recruiting |
| DaVita Clinical Research | Middlebury | Connecticut | Recruiting |
| PACT Kidney Care | Orange | Connecticut | Recruiting |
| US Renal Care - Fort Myers South | Fort Myers | Florida | Recruiting |
| Nephrology & Hypertension Specialists | Dalton | Georgia | Recruiting |
| St. Clair Nephrology Research | Shelby | Michigan | Recruiting |
| DaVita Clinical Research Edina | Edina | Minnesota | Recruiting |
| Johnson County Clinical Trials | Kansas City | Missouri | Recruiting |
| DaVita Clinical Research | Las Vegas | Nevada | Recruiting |
| R1 Therapeutics Clinical Trial Site | Albuquerque | New Mexico | Recruiting |
| NY Kidney & Hypertension Medicine | Ridgewood | New York | Recruiting |
| US Renal Care - Alexis | Toledo | Ohio | Recruiting |
| Sunbeam Research | Greenville | Texas | Recruiting |
| DaVita Clinical Research | Houston | Texas | Recruiting |
| Gamma Medical Research | McAllen | Texas | Recruiting |
| US Renal Care - South San Antonio | San Antonio | Texas | Recruiting |
| US Renal Care - Westover Hills | San Antonio | Texas | Recruiting |
| DaVita Clinical Research San Antonio | San Antonio | Texas | Recruiting |
| US Renal Care | Waxahachie | Texas | Recruiting |
| DaVita Clinical Research Norfolk | Norfolk | Virginia | Recruiting |
| Peking University First Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking University People's Hospital | Beijing | Beijing Municipality | Recruiting |
| Zhengzhou University-First Affiliated Hospital | Zhengzhou | Henan | Recruiting |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | Recruiting |
| Shanghai Jiao Tong University School of Medicine, Renji Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06712654 on ClinicalTrials.gov ↗ ← All trials in China