RECRUITING

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * What discomfort or medical problem do the patients have when taking AP301? * Does AP301 improve quality of life in Chinese patients? The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate. In the study, the patients will experience the following stages in a chronicle order: * Stop all using blood phosphate-lowering drugs, * Take AP301 or the comparator three times a day for 8 weeks, * Take AP301 three times a day for 24 weeks, and * Take AP301 or the comparator three times a day for 3 weeks. In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Official Title

A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

Quick Facts

Study Start:2025-06-06
Study Completion:2027-01-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06933472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated ICF
  2. * Adult when signing the ICF
  3. * Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
  4. * For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
  5. * Patients who receive phosphate binders over 4 weeks and their serum phosphate level is:
  6. 1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
  7. 2. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)
  1. * History or plan of kidney transplantation
  2. * History or plan of parathyroid intervention 6 months before signing the ICF
  3. * Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
  4. * Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
  5. * Presence of clinically significant gastrointestinal (GI) disorder
  6. * History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
  7. * Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
  8. * Female who are breastfeeding

Contacts and Locations

Study Contact

Weifeng Zhang, M.D.
CONTACT
+8618602184576
weifeng.zhang@alebund.com
Bobby Zang
CONTACT
+8613661683813
bobby.zang@alebund.com

Study Locations (Sites)

Rocky Mountain Kidney Care - Lone Tree
Lone Tree, Colorado, 80124
United States
PACT Kidney Care - Orange
Orange, Connecticut, 06477
United States
US Renal Care - Fort Myers South
Fort Myers, Florida, 33912
United States
Nephrology & Hypertension Specialists
Dalton, Georgia, 30720
United States
US Renal Care - West Cheektowaga
Cheektowaga, New York, 14215
United States
US Renal Care - Alexis
Toledo, Ohio, 43613
United States
US Renal Care - South San Antonio
San Antonio, Texas, 78211
United States

Collaborators and Investigators

Sponsor: Alebund Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-06
Study Completion Date2027-01-10

Study Record Updates

Study Start Date2025-06-06
Study Completion Date2027-01-10

Terms related to this study

Keywords Provided by Researchers

  • Hyperphosphatemia
  • AP301
  • Dialysis
  • ESKD

Additional Relevant MeSH Terms

  • Hyperphosphatemia
  • Chronic Kidney Disease, Receiving Dialysis
  • ESRD (End-Stage Renal Disease)
  • Dialysis