A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia

NCT06712654 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: AP306-HP-02
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if AP306 could work in the patients receiving maintenance hemodialysis with elevated blood phosphate. The main questions it aims to answer are:

• 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.

Conditions

Hyperphosphatemia; Chronic Kidney Disease Requiring Hemodialysis

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of AP306 assessed by serum phosphate lowering

  The change in serum phosphate from the baseline to the end of treatment or before the initiation of rescue therapy

  12 weeks

Other Outcomes (1)

• To evaluate the overall safety of AP306 assessed by incidence of treatment-emergent adverse events

  15 weeks

Study Arms (2)

AP306

EXPERIMENTAL

A blood phosphate-lowering medication with a novel mechanism

Drug: AP306 75mg TID; Drug: AP306 100mg TID; Drug: AP306 125mg TID; Drug: AP306 125mg BID; Drug: AP306 150mg BID

Placebo of AP306

PLACEBO COMPARATOR

Drug: Placebo TID

Interventions

AP306 75mg TID DRUG

receiving orally AP306 75mg (one tablet), three times a day

AP306

AP306 100mg TID DRUG

receiving orally AP306 100 mg (one tablet), three times a day.

AP306

AP306 125mg TID DRUG

receiving orally AP306 125 mg (one tablet), three times a day

AP306

AP306 125mg BID DRUG

receiving orally AP306 125 mg (one tablet), three times a day, among which one is a placebo tablet

AP306

AP306 150mg BID DRUG

receiving orally AP306 150 mg (one tablet), three times a day, among which one is a placebo tablet

AP306

Placebo TID DRUG

receiving orally one placebo tablet of AP306, three times a day

Placebo of AP306

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who signes a written informed consent form (ICF) and is willing to comply with all study requirements in the study
• 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
• Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening
• 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
• Who has a blood phosphate level within the study-required range

You may not qualify 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 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
• Uncontrolled blood calcium abnormality
• Uncontrolled blood intact parathyroid hormone abnormality
• Hemoglobin \<9 mg/dL (90 g/L)
• Acute hepatitis or significant chronic liver disease
• 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
• Uncontrolled hypertension
• Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to the ICF sign off
• Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test
• Any active infection or infestation or any treatment with antibiotics within 2 weeks prior to the ICF sign off
• 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
• 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)
• Treatment with any investigational medication or medical device within 30 days prior to the ICF sign off

Sponsors & Collaborators

• Alebund Pharmaceuticals: lead

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Weifeng Zhang

CONTACT

+8618602184576; weifeng.zhang@alebund.com

Jue Huang

CONTACT

+8613764056397; jue.huang@alebund.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: April 10, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11