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NCT06712654PHASE2Recruiting

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

R1 Therapeutics

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

Important Inclusion Criteria: * 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 * If the participant is receiving etelcalcetide, their doses must be unchanged for at least 4 weeks prior to signing the ICF * If the participant is receiving any of the following therapies, their doses are stable for at least 14 days prior to signing the ICF: phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D and analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors * Agreement to use highly effective contraception for women of childbearing potentially and non-sterile sexually active males throughout the study and for 90 days after the final dose of study drug Important Exclusion Criteria: * 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 * Adequate organ and bone marrow function * Acute hepatitis or significant chronic liver disease * Any clinically significant GI disorders within 4 weeks prior to signing the ICF; or any history of gastrectomy; or any GI tract surgery (excluding appendectomy and polypectomy), within 12 weeks of signing the ICF * Uncontrolled hypertension * Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to signing the ICF * Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test * Any clinically significant active infection or infestation or any treatment with systemic antimicrobial treatment within 2 weeks prior to signing the ICF * History or presence of malignancy within 3 years prior to signing the ICF, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer * Taking moderate or strong cytochrome P450 (CYP) 3A inhibitors within 2 weeks or 5 half-lives, whichever is longer, prior to signing the ICF (topical use is allowed) * Treatment with any investigational medication or medical device within 30 days prior to signing the ICF * Life expectancy less than 12 months

Interventions

DRUG

AP306 75 mg BID

DRUG

AP306 125 mg BID

DRUG

AP306 150 mg BID

DRUG

AP306 75 mg TID

DRUG

AP306 100 mg TID

DRUG

AP306 125 mg TID

DRUG

Placebo

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Conditions

HyperphosphatemiaChronic Kidney Disease Requiring Chronic DialysisEnd Stage Renal Disease on Dialysis

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