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

RecruitingPhase 2Ages 18 Years - anyAllR1 Therapeutics
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In plain words

What the trial is, and whether it could suit you

This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ1.20, at screening or any documented value โ‰ฅ1.20 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
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What it tests

  • AP306 75 mg BID
  • AP306 125 mg BID
  • AP306 150 mg BID
  • AP306 75 mg TID
  • AP306 100 mg TID
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Where

31 sites
Apogee Clinical Research, LLC
Huntsville, United States
California Institute of Renal Research
Chula Vista, United States
Academic Medical Research Institute
Los Angeles, United States
North America Research Institute
San Dimas, United States
Colorado Kidney Care
Denver, United States
DaVita Clinical Research
Middlebury, United States
PACT Kidney Care
Orange, United States
US Renal Care - Fort Myers South
Fort Myers, United States

โ€ฆand 23 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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