NCT06712654 A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
| NCT ID | NCT06712654 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | R1 Therapeutics |
| Condition | Hyperphosphatemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 168 participants in total. It began in 2026-06-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06712654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperphosphatemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712654 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06712654 currently recruiting?
Yes, NCT06712654 is actively recruiting participants. Contact the research team at ClinicalTrials@r1therapeutics.com for enrollment information.
Where is the NCT06712654 trial being conducted?
This trial is being conducted at Huntsville, United States, Chula Vista, United States, Los Angeles, United States, San Dimas, United States and 11 additional locations.
Who is sponsoring the NCT06712654 clinical trial?
NCT06712654 is sponsored by R1 Therapeutics. The trial plans to enroll 168 participants.