Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

NCT ID: NCT03984760

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2021-02-20

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

Detailed Description

This is a multicenter, randomized, open-label, active-controlled, parallel, phase III study which aims to assess the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). During the Treatment period, the subjects will be randomly assigned to the ferric citrate capsule group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.

Conditions

Hyperphosphatemia; End Stage Renal Disease; ESRD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric Citrate Capsule

Ferric Citrate Capsule, product specification: 500 mg/cap, manufactured by Panion \& BF Biotech Inc.

Group Type: EXPERIMENTAL

Ferric Citrate

Intervention Type: DRUG

Take the capsules with meals or immediately after meals.

Sevelamer Carbonate Tablet

Sevelamer carbonate tablet group, product specification: 800 mg/tablet, manufactured by Genzyme Ireland Limited

Group Type: ACTIVE_COMPARATOR

Sevelamer Carbonate

Intervention Type: DRUG

Take the tablets with meals.

Interventions

Ferric Citrate

Take the capsules with meals or immediately after meals.

Intervention Type: DRUG

Sevelamer Carbonate

Take the tablets with meals.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Willing to give written informed consent.;

2. Between the age of 18 and 75 years (including the boundary value);

3. Patients who maintain the hemodialysis schedule as 3 times a week and the dialysis schedule should remain unchanged during the study period;

4. 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;

5. 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.

Exclusion Criteria

1. Patients with severe gastrointestinal diseases (such as acute peptic ulcer, chronic ulcerative colitis, regional enteritis, ileus) or patients with dysphagia;

2. 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;

3. Patients with severe constipation (times of bowel movement≤ 1 time/week), chronic diarrhea (times of bowel movement≥ 4 times/day), severe gastrointestinal motility disorder;

4. 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;

5. 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;

6. Patients with intact-PTH>800pg/mL at Screening, or patients undergone parathyroid surgery within 6 months prior to Screening or requiring parathyroid surgery;

7. Patients who received blood transfusions for treating anemia within 3 months prior to Screening;

8. 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;

9. Patients who require citrate preparation as an anticoagulant during hemodialysis treatment during the study period;

10. 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;

11. 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;

12. Patients who are known to be intolerant to sevelamer carbonate tablet;

13. Patients with a history of allergies to iron preparations or those who are intolerant to iron preparations;

14. Patients who are scheduled to have a kidney transplant during the study period;

15. Patients with a current or past history of malignancy within 5 years prior to Screening;

16. Women who are pregnant or lactating, or patients who are unable to take effective contraception from screening to 6 months after discontinuation (including male subjects and their female spouses);

17. Patients who had participated in other clinical studies and other received investigational drug product within 1 month or 5 half-lives of the drug product (whichever is longer) prior to Screening;

18. Patients who are not suitable for participating in the trial according to the investigator's judgment;

19. Patients who are unwilling or unable to follow the protocol process.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Weigao Panion Pharmaceutical Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

Panion & BF Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangmei Chen

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of the People's Liberation Army (PLAGH)

Locations

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Other Identifiers

WG-PBB00302

Identifier Type: -

Identifier Source: org_study_id