A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia
NCT ID: NCT06712654
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2025-04-10
2025-12-30
Brief Summary
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* Does AP306 lower blood phosphate levels when the participants take a fixed dose of AP306?
* What medical problems do the participants have when taking AP306?
The researchers will compare AP306 to a placebo (a look-alike substance that contains no drug) to see if AP306 works to treat hyperphosphatemia.
The participants will:
* Stop all using blood phosphate-lowering drugs, and
* Take AP306 or a placebo three times a day for 12 weeks.
If the participant has a blood phosphate level above a certain level, they will receive additional treatment to lower the blood phosphate level.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AP306
A blood phosphate-lowering medication with a novel mechanism
AP306 75mg TID
receiving orally AP306 75mg (one tablet), three times a day
AP306 100mg TID
receiving orally AP306 100 mg (one tablet), three times a day.
AP306 125mg TID
receiving orally AP306 125 mg (one tablet), three times a day
AP306 125mg BID
receiving orally AP306 125 mg (one tablet), three times a day, among which one is a placebo tablet
AP306 150mg BID
receiving orally AP306 150 mg (one tablet), three times a day, among which one is a placebo tablet
Placebo of AP306
Placebo TID
receiving orally one placebo tablet of AP306, three times a day
Interventions
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AP306 75mg TID
receiving orally AP306 75mg (one tablet), three times a day
AP306 100mg TID
receiving orally AP306 100 mg (one tablet), three times a day.
AP306 125mg TID
receiving orally AP306 125 mg (one tablet), three times a day
AP306 125mg BID
receiving orally AP306 125 mg (one tablet), three times a day, among which one is a placebo tablet
AP306 150mg BID
receiving orally AP306 150 mg (one tablet), three times a day, among which one is a placebo tablet
Placebo TID
receiving orally one placebo tablet of AP306, three times a day
Eligibility Criteria
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Inclusion Criteria
2. Who is receiving a stable hemodialysis regimen, which is defined as a frequency of three times per week for at least 12 weeks before the ICF sign off, and doesn't plan to change in the study
3. Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening
4. If the participant is receiving any of the following therapies, their doses are stable for at least 4 weeks before the ICF sign off visit: phosphate-lowering products other than phosphate binders, active vitamin D and analogs or nutritional vitamin D, calcimimetics, calcitonin, and P-glycoprotein inhibitors or inducers
5. Who has a blood phosphate level within the study-required range
Exclusion Criteria
2. 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
3. Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study
4. Uncontrolled blood calcium abnormality
5. Uncontrolled blood intact parathyroid hormone abnormality
6. Hemoglobin \<9 mg/dL (90 g/L)
7. Acute hepatitis or significant chronic liver disease
8. Any clinically significant GI disorders within 4 weeks prior to the ICF sign off; or any history of gastrectomy; or any GI tract surgery, excluding appendectomy and polypectomy, within 12 weeks prior to the ICF sign off
9. Uncontrolled hypertension
10. Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to the ICF sign off
11. Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test
12. Any active infection or infestation or any treatment with antibiotics within 2 weeks prior to the ICF sign off
13. History or presence of malignancy within 3 years prior to the ICF sign off, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer
14. Concomitant use of moderate or strong cytochrome P450 (CYP) 3A inhibitors or inducers within 2 weeks or 5 half-lives, whichever is longer, prior to the ICF sign off (topical use is allowed)
15. Treatment with any investigational medication or medical device within 30 days prior to the ICF sign off
18 Years
ALL
No
Sponsors
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Alebund Pharmaceuticals
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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AP306-HP-02
Identifier Type: -
Identifier Source: org_study_id