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AP306 for High Phosphate Levels in Dialysis Patients

This study is testing a new medication called AP306 for people on dialysis who have hyperphosphatemia (high phosphate levels in the blood). High phosphate levels are common in people with advanced kidney disease and can lead to other health problems. AP306 is designed to help lower phosphate by stopping its absorption in the gut. Researchers want to see how safe AP306 is, how well people tolerate it, and if different doses (75 mg, 100 mg, 125 mg, or 150 mg, taken twice or three times a day) can effectively lower phosphate levels over 8 weeks. The study plans to enroll 168 adults who are receiving stable hemodialysis.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive AP306 or a placebo (an inactive substance), and neither you nor your doctor will know which you are receiving. The study aims to enroll 168 participants.
What's involved
You would take AP306 or a placebo by mouth daily for 8 weeks. You must be receiving stable hemodialysis three times per week for at least 12 weeks before joining.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure phosphate levels at 8 weeks after starting treatment.

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NCT06712654

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
R1 Therapeutics
~168 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:AP306 75 mg BIDAP306 125 mg BIDAP306 150 mg BIDAP306 75 mg TIDAP306 100 mg TIDAP306 125 mg TID

At a glance

Recruiting sites
31 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis
Measured over 8 weeks

Conditions

Hyperphosphatemia
Chronic Kidney Disease Requiring Chronic Dialysis
End Stage Renal Disease on Dialysis

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Chronic Kidney DiseaseChronic Kidney Disease, Stage 5Hyperphosphatemia

Where it's being run

31 sites across 20 states
Texas7
California3
Connecticut2
Beijing Municipality2
Jiangsu2
Alabama1
Colorado1
Florida1

Who to contact

Clinical Trials Information
[email protected]
(844) 697-3339
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis8 weeks

    The change in serum phosphate from baseline to the end of treatment or before the initiation of rescue therapy, or before the interruption of study drug due to serum phosphate \<2.5 mg/dL (0.81 mmol/L)