AP306 at fixed doses in adults on dialysis with high phosphate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, and efficacy of AP306 at fixed daily doses for 8 weeks in adults with hyperphosphatemia undergoing maintenance hemodialysis. Participants will receive one of several AP306 dosing regimens or placebo to see if the drug reduces serum phosphate without unacceptable side effects. The study targets adults on stable dialysis regimens and requires specific phosphate and dialysis adequacy criteria to be met at screening. Primary goals focus on safety and tolerability, with secondary aims to observe changes in phosphate levels and other relevant outcomes. The trial is conducted at multiple clinical centers under a lead sponsor and collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Apogee Clinical Research, LLC
  Huntsville, Alabama, United States Recruiting
• California Institute of Renal Research
  Chula Vista, California, United States Recruiting
• Academic Medical Research Institute
  Los Angeles, California, United States Recruiting
• North America Research Institute
  San Dimas, California, United States Recruiting
• Colorado Kidney Care
  Denver, Colorado, United States Recruiting
• DaVita Clinical Research
  Middlebury, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Information
• Email: ClinicalTrials@r1therapeutics.com
• Phone: (844) 697-3339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.