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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

Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

• Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:

‣ 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)

Locations
United States
California
Renal Consultants Medical Group
RECRUITING
Granada Hills
North America Research Institute - San Dimas
RECRUITING
San Dimas
North America Research Institute - San Dimas
RECRUITING
San Dimas
Colorado
Rocky Mountain Kidney Care - Lone Tree
RECRUITING
Lone Tree
Connecticut
PACT Kidney Care - Orange
RECRUITING
Orange
Florida
US Renal Care - Fort Myers South
RECRUITING
Fort Myers
Georgia
Nephrology & Hypertension Specialists
RECRUITING
Dalton
Louisiana
Renal Associates Of Baton Rouge, LLC
RECRUITING
Baton Rouge
Mississippi
Nephrology Associates, P.C. - Columbus
RECRUITING
Columbus
Nephrology & Hypertension Associates Ltd - Tupelo
RECRUITING
Tupelo
New Mexico
High Desert Nephrology Association - US Renal Care
RECRUITING
Gallup
New York
US Renal Care - West Cheektowaga
RECRUITING
Cheektowaga
NY Kidney & Hypertension Medicine
RECRUITING
Ridgewood
Ohio
US Renal Care - Alexis
RECRUITING
Toledo
Texas
Dallas Renal Group - Dallas
RECRUITING
Dallas
US Renal Care - Bluebonnet
RECRUITING
Fort Worth
Gamma Medical Research
RECRUITING
Mcallen
US Renal Care - Hill Country
RECRUITING
San Antonio
US Renal Care - South San Antonio
RECRUITING
San Antonio
Other Locations
China
Beijing Tsinghua Chang Gung Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University International Hospital
RECRUITING
Beijing
Central South University-The Third Xiangya Hospital
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
RECRUITING
Nanjing
Southeast University-Zhongda Hospital
RECRUITING
Nanjing
Nantong University-Affiliated Hospital
RECRUITING
Nantong
Qingdao University-The Affiliated Hospital
RECRUITING
Qingdao
Children's Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Fudan University-Huashan Hospital
RECRUITING
Shanghai
Fudan University-Zhongshan Hospital
RECRUITING
Shanghai
Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital
RECRUITING
Shanghai
Shanghai Tongren Hospital
RECRUITING
Shanghai
Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospital
RECRUITING
Wuhan
Wuhan University People's Hospital
RECRUITING
Wuhan
Nanjing Medical University-Wuxi People's Hospital (Wuxi No.1 People's Hospital)
RECRUITING
Wuxi
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Subei People's Hospital
RECRUITING
Yangzhou
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Zhengzhou University-First Affiliated Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Weifeng Zhang, M.D.
weifeng.zhang@alebund.com
+8618602184576
Backup
Bobby Zang
bobby.zang@alebund.com
+8613661683813
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2027-01-10
Participants
Target number of participants: 264
Treatments
Experimental: AP301
A blood phosphate-lowering medication containing iron
Experimental: AP301 Low Dose
A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective
Related Therapeutic Areas
Sponsors
Collaborators: Fortrea
Leads: Alebund Pharmaceuticals

This content was sourced from clinicaltrials.gov