Recruiting
Phase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Condition(s) studied
HyperphosphatemiaChronic Kidney Disease Requiring Chronic DialysisEnd Stage Renal Disease on Dialysis
Investigational drug(s) / intervention(s)
AP306 75 mg BIDAP306 125 mg BIDAP306 150 mg BIDAP306 75 mg TIDAP306 100 mg TIDAP306 125 mg TIDPlacebo
AP306 75 mg BID: AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 125 mg BID: AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 150 mg BID: AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 75 mg TID: AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
AP306 100 mg TID: AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
AP306 125 mg TID: AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
Placebo: Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.
Study 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
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
Primary outcome measure(s)
- To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis — 8 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)
Trial sites (31)
| Facility | City | Region | Status |
| Apogee Clinical Research, LLC |
Huntsville |
Alabama |
Recruiting |
| California Institute of Renal Research |
Chula Vista |
California |
Recruiting |
| Academic Medical Research Institute |
Los Angeles |
California |
Recruiting |
| North America Research Institute |
San Dimas |
California |
Recruiting |
| Colorado Kidney Care |
Denver |
Colorado |
Recruiting |
| DaVita Clinical Research |
Middlebury |
Connecticut |
Recruiting |
| PACT Kidney Care |
Orange |
Connecticut |
Recruiting |
| US Renal Care - Fort Myers South |
Fort Myers |
Florida |
Recruiting |
| Nephrology & Hypertension Specialists |
Dalton |
Georgia |
Recruiting |
| St. Clair Nephrology Research |
Shelby |
Michigan |
Recruiting |
| DaVita Clinical Research Edina |
Edina |
Minnesota |
Recruiting |
| Johnson County Clinical Trials |
Kansas City |
Missouri |
Recruiting |
| DaVita Clinical Research |
Las Vegas |
Nevada |
Recruiting |
| R1 Therapeutics Clinical Trial Site |
Albuquerque |
New Mexico |
Recruiting |
| NY Kidney & Hypertension Medicine |
Ridgewood |
New York |
Recruiting |
| US Renal Care - Alexis |
Toledo |
Ohio |
Recruiting |
| Sunbeam Research |
Greenville |
Texas |
Recruiting |
| DaVita Clinical Research |
Houston |
Texas |
Recruiting |
| Gamma Medical Research |
McAllen |
Texas |
Recruiting |
| US Renal Care - South San Antonio |
San Antonio |
Texas |
Recruiting |
| US Renal Care - Westover Hills |
San Antonio |
Texas |
Recruiting |
| DaVita Clinical Research San Antonio |
San Antonio |
Texas |
Recruiting |
| US Renal Care |
Waxahachie |
Texas |
Recruiting |
| DaVita Clinical Research Norfolk |
Norfolk |
Virginia |
Recruiting |
| Peking University First Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| Peking University People's Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| Zhengzhou University-First Affiliated Hospital |
Zhengzhou |
Henan |
Recruiting |
| The Second Affiliated Hospital of Nanjing Medical University |
Nanjing |
Jiangsu |
Recruiting |
| Zhongda Hospital Southeast University |
Nanjing |
Jiangsu |
Recruiting |
| Shanghai Jiao Tong University School of Medicine, Renji Hospital |
Shanghai |
Shanghai Municipality |
Recruiting |
| Sichuan Provincial People's Hospital |
Chengdu |
Sichuan |
Recruiting |
Other trials for the same condition