RecruitingPhase 2NCT06712654

A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Participants With Hyperphosphatemia Receiving Maintenance Hemodialysis

Sponsor

R1 Therapeutics

Enrollment

168 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

End Stage Renal Disease on Dialysis Hyperphosphatemia Chronic Kidney Disease Requiring Chronic Dialysis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AP306 100 mg TID, a drug called AP306 125 mg BID, and others for people with chronic kidney disease requiring chronic dialysis, end stage renal disease on dialysis, and other related conditions. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAP306 75 mg BID

AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.

DRUGAP306 125 mg BID

AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.

DRUGAP306 150 mg BID

AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.

DRUGAP306 75 mg TID

AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.

DRUGAP306 100 mg TID

AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.

DRUGAP306 125 mg TID

AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.

DRUGPlacebo

Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.

Locations(26)

Apogee Clinical Research, LLC

Huntsville, Alabama, United States

California Institute of Renal Research

Chula Vista, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

Colorado Kidney Care

Denver, Colorado, United States

DaVita Clinical Research

Middlebury, Connecticut, United States

US Renal Care

Orange, Connecticut, United States

US Renal Care

Fort Myers, Florida, United States

US Renal Care

Dalton, Georgia, United States

St. Clair Nephrology Research

Shelby, Michigan, United States

Johnson County Clinical Trials

Kansas City, Missouri, United States

DaVita Clinical Research

Las Vegas, Nevada, United States

Renal Medicines Associates

Albuquerque, New Mexico, United States

US Renal Care

Toledo, Ohio, United States

Sunbeam Research

Greenville, Texas, United States

DaVita Clinical Research

Houston, Texas, United States

Gamma Medical Research

McAllen, Texas, United States

US Renal Care

San Antonio, Texas, United States

DaVita Clinical Research

San Antonio, Texas, United States

DaVita Clinical Research

Norfolk, Virginia, United States

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Zhengzhou University-First Affiliated Hospital

Zhengzhou, Henan, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Shanghai Jiao Tong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06712654

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