Tests AP306 in adults with high phosphate on dialysis
Tests AP306 against placebo in adults with high phosphate on dialysis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Key facts
- Where
- Beijing, Chengdu, Nanjing, Shanghai, and Zhengzhou, ChinaSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high blood phosphate who are on stable hemodialysis three times a week. It tests AP306 against placebo.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- High blood phosphate (hyperphosphatemia) in people on maintenance hemodialysis, with a blood phosphate level in the range the study requires and dialysis adequacy (SpKt/V) of 1.20 or more.
- Earlier treatment
- Stable hemodialysis three times a week for at least 12 weeks. Etelcalcetide doses unchanged for at least 4 weeks. Doses of phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D, cinacalcet, calcitonin and P-glycoprotein inhibitors stable for at least 14 days.
- Biomarker or test result
- Blood phosphate level within the study-required range. Dialysis adequacy (SpKt/V) of 1.20 or more.
Main reasons for not taking part
- Pregnant or breastfeeding
- Planned kidney transplant from a living donor in the next 6 months, or planned change of dialysis type or center
- Abnormal blood calcium or parathyroid hormone, or a parathyroid procedure in the last 6 months
- Significant liver disease, stomach or bowel disorders, or uncontrolled high blood pressure
- Cancer in the last 3 years (some skin and in-situ cancers allowed), or life expectancy under 12 months
This trial only enrols participants on dialysis. The registry sentence this rests on: 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
Read by machine on 9 November 2026.
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- Zhongda Hospital Southeast UniversityNanjing, ChinaTaking people
- Shanghai Jiao Tong University School of Medicine, Renji HospitalShanghai, ChinaTaking people
- Zhengzhou University - First Affiliated HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- R1 Therapeutics
- Trial code
- NCT06712654
- Record updated
- 26 August 2026
- Original description
This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.Read full original descriptionShow less
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
This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
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.