Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Study to Assess the Efficacy and Safety of Ferric Citrate Capsules for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
1 other identifier
interventional
240
1 country
24
Brief Summary
To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedStudy Start
First participant enrolled
June 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2021
CompletedMarch 10, 2021
March 1, 2021
1.7 years
June 5, 2019
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in serum phosphorus levels
The change in serum phosphorus levels at the end of treatment (Visit 10 or ET) as compared to baseline (before the first dose).
12 Weeks
Secondary Outcomes (6)
Serum phosphorus levels
12 Weeks
The proportion of subjects whose serum phosphorus levels reached the target range.
12 Weeks
The response rate of serum phosphorus
12 Weeks
The change in serum calcium (corrected) levels
12 Weeks
The change in the [Ca] × [P] product relative
12 Weeks
- +1 more secondary outcomes
Study Arms (2)
Ferric Citrate Capsule
EXPERIMENTALFerric Citrate Capsule, product specification: 500 mg/cap, manufactured by Panion \& BF Biotech Inc.
Sevelamer Carbonate Tablet
ACTIVE COMPARATORSevelamer carbonate tablet group, product specification: 800 mg/tablet, manufactured by Genzyme Ireland Limited
Interventions
Eligibility Criteria
You may qualify if:
- Willing to give written informed consent.;
- Between the age of 18 and 75 years (including the boundary value);
- Patients who maintain the hemodialysis schedule as 3 times a week and the dialysis schedule should remain unchanged during the study period;
- At Screening, patients who have received phosphate binder for at least 4 weeks and have a serum phosphorus level between 2.5 and 8.0 mg/dL (0.81 to 2.58 mmol/L) (excluding the boundary value) after treatment;
- Patients with a serum phosphorus level between 5.5 and 10.0 mg/dL (1.78 to 3.23 mmol/L) (excluding the boundary value) after washout.
You may not qualify if:
- Patients with severe gastrointestinal diseases (such as acute peptic ulcer, chronic ulcerative colitis, regional enteritis, ileus) or patients with dysphagia;
- Patients with a history of gastrectomy or enterectomy (excluding endoscopic excision or caecectomy) or patients who had undergone gastrointestinal surgery within 3 months prior to Screening;
- Patients with severe constipation (times of bowel movement≤ 1 time/week), chronic diarrhea (times of bowel movement≥ 4 times/day), severe gastrointestinal motility disorder;
- Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with a serum ferritin level \>800 ng/mL or TSAT \>50% at Screening;
- Patients with a serum calcium level (corrected) \<8.0 mg/dL (2.0 mmol/L) or \>11.0 mg/dL (2.75 mmol/L) after washout;
- Patients with intact-PTH\>800pg/mL at Screening, or patients undergone parathyroid surgery within 6 months prior to Screening or requiring parathyroid surgery;
- Patients who received blood transfusions for treating anemia within 3 months prior to Screening;
- Patients who require phosphorus-binding agents containing aluminum, magnesium, calcium and lanthanum in addition to the study drug or patients who require an antacid with a phosphorus binding effect during the study period;
- Patients who require citrate preparation as an anticoagulant during hemodialysis treatment during the study period;
- Patients with impaired liver function (hepatic dysfunction or serum total bilirubin, aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of normal) or patients with cirrhosis;
- Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification, acute myocardial infarction, unstable angina, etc.) requiring hospitalization within 6 months prior to Screening;
- Patients who are known to be intolerant to sevelamer carbonate tablet;
- Patients with a history of allergies to iron preparations or those who are intolerant to iron preparations;
- Patients who are scheduled to have a kidney transplant during the study period;
- Patients with a current or past history of malignancy within 5 years prior to Screening;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Baotou Central Hospital
Baotou, China
The General Hospital of the People's Liberation Army (PLAGH)
Beijing, China
The Second Hospital of Jilin University
Changchun, China
Daping Hospital
Chongqing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital/School Of Clinical Medicine of Guangdong Pharmaceutical University
Guangzhou, China
Jilin Guowen Hospital
Jilin, China
Jiujiang University Affiliated Hospital
Jiujiang, China
Meihekou Central Hospital
Meihekou, China
Jiangxi Provincial People's Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
BenQ Medical Center
Nanjing, China
JiangSu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Changhai Hospital
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
Tonghua Central Hospital
Tonghua, China
Fifth Hospital in Wuhan
Wuhan, China
Renmin Hospital of Wuhan University
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Henan Provincial People's Hospital
Zhengzhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, China
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangmei Chen
The General Hospital of the People's Liberation Army (PLAGH)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 13, 2019
Study Start
June 19, 2019
Primary Completion
February 20, 2021
Study Completion
February 20, 2021
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share