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Tests treatment safety and results for Hyperphosphatemia
Official title A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
ClinicalTrials.gov ID: NCT06712654
What this study is testing
What is AP306 75 mg BID?
AP306 75 mg BID is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hyperphosphatemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Important
- 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...
- 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...
You likely can't join if
- 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...
- Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the...
- Blood calcium or blood intact parathyroid hormone abnormality
- Adequate organ and bone marrow function
- Acute hepatitis or significant chronic liver disease
See the full eligibility criteria
- Important
- 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Chula Vista, California, United States
- Los Angeles, California, United States
- San Dimas, California, United States
- Denver, Colorado, United States
- Middlebury, Connecticut, United States
- Orange, Connecticut, United States
- Fort Myers, Florida, United States
- Dalton, Georgia, United States
- Shelby, Michigan, United States
- Edina, Minnesota, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
- Ridgewood, New York, United States
- Toledo, Ohio, United States
- Greenville, Texas, United States
- Houston, Texas, United States
- McAllen, Texas, United States
- San Antonio, Texas, United States
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Chula Vista, California, United States; Los Angeles, California, United States; San Dimas, California, United States; Denver, Colorado, United States; Middlebury, Connecticut, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.