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Clinical Trials in the USA / NCT06712654
Recruiting Phase 2

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

NCT06712654 · tracked via the Priya Life Science USA tracker
Sponsor
R1 Therapeutics
Phase
Phase 2
Started
2026-06-01
Last updated
2026-08-26

Condition(s) studied

HyperphosphatemiaChronic Kidney Disease Requiring Chronic DialysisEnd Stage Renal Disease on Dialysis

Investigational drug(s) / intervention(s)

AP306 75 mg BIDAP306 125 mg BIDAP306 150 mg BIDAP306 75 mg TIDAP306 100 mg TIDAP306 125 mg TIDPlacebo

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
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

Official registry record

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 the USA