What is AP306 studying for hyperphosphatemia in dialysis patients?

AP306 is being studied to evaluate its safety, tolerability, and ability to lower serum phosphate levels in adults with hyperphosphatemia who are receiving maintenance hemodialysis. This research aims to better understand how fixed doses of AP306 affect phosphate control, which is important for reducing risks associated with kidney disease. The study is sponsored by R1 Therapeutics.

Who may be eligible for this hyperphosphatemia clinical trial?

Adults aged 18 and older who have hyperphosphatemia and are receiving stable maintenance hemodialysis three times per week may be eligible. Both men and women can participate if they meet other health requirements, such as stable medication doses and certain blood phosphate levels. Please review eligibility criteria for more details.

Is there any cost to participate in this hyperphosphatemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06712654

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

Led by R1 Therapeutics · Updated on 2026-06-08

168

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of AP306 at fixed doses in adults with hyperphosphatemia who are receiving maintenance hemodialysis. Hyperphosphatemia is a common complication in advanced chronic kidney disease and is linked to serious risks such as cardiovascular problems, fractures, and mortality, especially in dialysis patients. This research is a randomized, double-blind, placebo-controlled Phase 2b study to better understand how AP306 affects phosphate levels in this population. Participants will receive AP306 in different fixed doses administered orally either twice or three times daily for 8 weeks, or a placebo given three times daily. The study includes seven different cohorts, six receiving various doses of AP306 and one receiving placebo. The treatment period aims to assess how these doses impact serum phosphate levels and the drugs safety and tolerability. During the study, participants will have their serum phosphate levels monitored to measure the drugs impact over the 8-week treatment period. Researchers will also assess the proportion of participants achieving target phosphate levels and the time it takes to see a response. Safety monitoring will include laboratory tests and assessments of adverse effects. The study expects full participation to span at least 8 weeks of treatment, with ongoing evaluation of tolerability and efficacy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed written informed consent and willingness to comply with study requirements
Receiving stable hemodialysis regimen three times per week for at least 12 weeks prior to consent
Blood phosphate level within the study-required range
Dialysis adequacy with single pooled Kt/V 651.20 at screening or documented within 12 weeks prior
Stable doses of etelcalcetide for at least 4 weeks if applicable
Stable doses of phosphate-lowering products (excluding tenapanor), active vitamin D analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors for at least 14 days
Agreement to use highly effective contraception for women of childbearing potential and non-sterile sexually active males during study and for 90 days after last dose

You will not qualify if you...

Pregnant or breastfeeding
Scheduled living donor kidney transplant within 6 months or planned dialysis modality change or relocation during study
History or planned non-pharmacological parathyroid intervention within 6 months or during study
Blood calcium or intact parathyroid hormone abnormalities
Acute hepatitis or significant chronic liver disease
Clinically significant gastrointestinal disorders within 4 weeks or history of gastrectomy or GI surgery (excluding appendectomy and polypectomy) within 12 weeks
Uncontrolled hypertension
Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks
Significant ECG abnormalities including QT interval and heart rhythm
Active infection or antimicrobial treatment within 2 weeks
History or presence of malignancy within 3 years except certain skin or in-situ cancers
Use of moderate or strong CYP3A inhibitors within 2 weeks or 5 half-lives prior to consent
Treatment with investigational medication or device within 30 days
Life expectancy less than 12 months

Research Team

Clinical Trials Information

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