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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984760
• Other study ID #: WG-PBB00302
• Status: Completed
• Phase: Phase 3
• Start date: June 19, 2019
• Est. completion date: February 20, 2021

Study information

• Verified date: March 2021
• Source: Panion & BF Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 20, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• ESRD
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Ferric Citrate
Take the capsules with meals or immediately after meals.
• Sevelamer Carbonate
Take the tablets with meals.

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Panion & BF Biotech Inc.	Shandong Weigao Panion Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum phosphorus levels	Serum phosphorus levels at the end of treatment;	12 Weeks
Secondary	The proportion of subjects whose serum phosphorus levels reached the target range.	The proportion of subjects whose serum phosphorus levels reached the target range (3.5 to 5.5 mg/dL, 1.13 to 1.78 mmol/L) at the end of the treatment;	12 Weeks
Secondary	The response rate of serum phosphorus	The response rate of serum phosphorus at the end of treatment (defined as reduction of the serum phosphorus level exceeds 25% as compared to baseline);	12 Weeks
Secondary	The change in serum calcium (corrected) levels	The change in serum calcium (corrected) levels at the end of treatment as compared to baseline;	12 Weeks
Secondary	The change in the [Ca] × [P] product relative	The change in the [Ca] × [P] product relative at the end of treatment as compared to baseline;	12 Weeks
Secondary	The change in the level of intact-PTH levels	The change in the level of intact-PTH levels at the end of treatment as compared to baseline.	12 Weeks