Hyperphosphatemia study: AP301 vs AP301 Low Dose
Official title A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
ClinicalTrials.gov ID: NCT06933472
What this study is testing
What is AP301?
AP301 is an investigational oral medicine being studied to help lower high blood phosphate levels in people on dialysis.
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 checks if the new medicine AP301 lowers blood phosphate levels. It also looks at how it affects calcium, parathyroid hormone, and daily comfort.
- Who it's for
- People with end-stage kidney disease who are on dialysis and have high blood phosphate.
- What's involved
- Participants will stop their current phosphate-lowering drugs. They will take AP301 or a look-alike pill three times a day for several months, with doses adjusted as needed.
- Time commitment
- The study lasts about 35 weeks and involves regular visits to check blood levels and adjust the dose.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Provision of signed and dated ICF
- Age ≥ 12 years when signing the ICF
- Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
- For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
- Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
You likely can't join if
- History or plan of kidney transplantation
- History or plan of parathyroid intervention 6 months before signing the ICF
- Serum calcium \ 2.75 mmol/L (11 mg/dL) at screening
- Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
- Presence of clinically significant gastrointestinal (GI) disorder
- History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
See the full eligibility criteria
- Provision of signed and dated ICF
- Age ≥ 12 years when signing the ICF
- Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
- For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
- Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
- After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL) Key
- History or plan of kidney transplantation
- History or plan of parathyroid intervention 6 months before signing the ICF
- Serum calcium \ 2.75 mmol/L (11 mg/dL) at screening
- Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
- Presence of clinically significant gastrointestinal (GI) disorder
- History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
- Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
- Female who are breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Granada Hills, California, United States
- San Dimas, California, United States
- Lone Tree, Colorado, United States
- Orange, Connecticut, United States
- Fort Myers, Florida, United States
- Dalton, Georgia, United States
- Baton Rouge, Louisiana, United States
- Columbus, Mississippi, United States
- Tupelo, Mississippi, United States
- Gallup, New Mexico, United States
- Cheektowaga, New York, United States
- Ridgewood, New York, United States
- Toledo, Ohio, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- McAllen, Texas, United States
- San Antonio, Texas, United States
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Zhengzhou, Henan, China
+ 11 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, but 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Granada Hills, California, United States; San Dimas, California, United States; Lone Tree, Colorado, United States; Orange, Connecticut, United States; Fort Myers, Florida, United States; Dalton, Georgia, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.