Actively Recruiting
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Adults Receiving Maintenance Hemodialysis With Hyperphosphatemia
Led by R1 Therapeutics · Updated on 2026-06-08
168
Participants Needed
26
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
R1 Therapeutics
Lead Sponsor
A
Alebund Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of AP306 at fixed doses in adults with hyperphosphatemia who are receiving maintenance hemodialysis. Hyperphosphatemia is a common complication in advanced chronic kidney disease and is linked to serious risks such as cardiovascular problems, fractures, and mortality, especially in dialysis patients. This research is a randomized, double-blind, placebo-controlled Phase 2b study to better understand how AP306 affects phosphate levels in this population. Participants will receive AP306 in different fixed doses administered orally either twice or three times daily for 8 weeks, or a placebo given three times daily. The study includes seven different cohorts, six receiving various doses of AP306 and one receiving placebo. The treatment period aims to assess how these doses impact serum phosphate levels and the drug's safety and tolerability. During the study, participants will have their serum phosphate levels monitored to measure the drug's impact over the 8-week treatment period. Researchers will also assess the proportion of participants achieving target phosphate levels and the time it takes to see a response. Safety monitoring will include laboratory tests and assessments of adverse effects. The study expects full participation to span at least 8 weeks of treatment, with ongoing evaluation of tolerability and efficacy.
CONDITIONS
Brief Title
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and willingness to comply with study requirements
- Receiving stable hemodialysis regimen three times per week for at least 12 weeks prior to consent
- Blood phosphate level within the study-required range
- Dialysis adequacy with single pooled Kt/V 651.20 at screening or documented within 12 weeks prior
- Stable doses of etelcalcetide for at least 4 weeks if applicable
- Stable doses of phosphate-lowering products (excluding tenapanor), active vitamin D analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors for at least 14 days
- Agreement to use highly effective contraception for women of childbearing potential and non-sterile sexually active males during study and for 90 days after last dose
You will not qualify if you...
- Pregnant or breastfeeding
- Scheduled living donor kidney transplant within 6 months or planned dialysis modality change or relocation during study
- History or planned non-pharmacological parathyroid intervention within 6 months or during study
- Blood calcium or intact parathyroid hormone abnormalities
- Acute hepatitis or significant chronic liver disease
- Clinically significant gastrointestinal disorders within 4 weeks or history of gastrectomy or GI surgery (excluding appendectomy and polypectomy) within 12 weeks
- Uncontrolled hypertension
- Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks
- Significant ECG abnormalities including QT interval and heart rhythm
- Active infection or antimicrobial treatment within 2 weeks
- History or presence of malignancy within 3 years except certain skin or in-situ cancers
- Use of moderate or strong CYP3A inhibitors within 2 weeks or 5 half-lives prior to consent
- Treatment with investigational medication or device within 30 days
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive daily doses of AP306 or placebo to evaluate safety, tolerability, and phosphate lowering effects.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 26 locations
1
Apogee Clinical Research, LLC
Huntsville, Alabama, United States, 35801
Not Yet Recruiting
2
California Institute of Renal Research
Chula Vista, California, United States, 91910
Not Yet Recruiting
3
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Not Yet Recruiting
4
Colorado Kidney Care
Denver, Colorado, United States, 80220
Not Yet Recruiting
5
DaVita Clinical Research
Middlebury, Connecticut, United States, 06762
Actively Recruiting
6
US Renal Care
Orange, Connecticut, United States, 06477
Not Yet Recruiting
7
US Renal Care
Fort Myers, Florida, United States, 33912
Not Yet Recruiting
8
US Renal Care
Dalton, Georgia, United States, 30720
Not Yet Recruiting
9
St. Clair Nephrology Research
Shelby, Michigan, United States, 48315
Actively Recruiting
10
Johnson County Clinical Trials
Kansas City, Missouri, United States, 64111
Not Yet Recruiting
11
DaVita Clinical Research
Las Vegas, Nevada, United States, 89107
Not Yet Recruiting
12
Renal Medicines Associates
Albuquerque, New Mexico, United States, 87109
Not Yet Recruiting
13
US Renal Care
Toledo, Ohio, United States, 43613
Not Yet Recruiting
14
Sunbeam Research
Greenville, Texas, United States, 75402
Not Yet Recruiting
15
DaVita Clinical Research
Houston, Texas, United States, 77054
Actively Recruiting
16
Gamma Medical Research
McAllen, Texas, United States, 78503
Not Yet Recruiting
17
US Renal Care
San Antonio, Texas, United States, 78251
Not Yet Recruiting
18
DaVita Clinical Research
San Antonio, Texas, United States, 78258
Not Yet Recruiting
19
DaVita Clinical Research
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
20
Peking University First Hospital
Beijing, Beijing Municipality, China, 100035
Not Yet Recruiting
21
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
22
Zhengzhou University-First Affiliated Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
23
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210003
Not Yet Recruiting
24
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
25
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 201112
Not Yet Recruiting
26
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
Research Team
C
Clinical Trials Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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