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

End Stage Renal Disease Clinical Trial

Official title:

A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456803
• Other study ID #: CTS-CO-1642
• Secondary ID: CTR20190978
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2019
• Est. completion date: September 13, 2022

Study information

• Verified date: April 2024
• Source: Sinomune Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of ferric citrate tablet in the control of serum phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.

Description:

This is a multicenter, randomized, open-label, parallel, phase III study. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). The subjects with regular hemodialysis should stop using the phosphorus binder before the Washout period. During the Treatment period, the subjects will be randomly assigned to the ferric citrate tablets group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Between the age of 18 and 75 years (including the boundary value) and no gender limitation;

2. Patients who maintain the hemodialysis schedule (including hemofiltration (HF) hemodialysis (HDF) hemoperfusion (HP)) as not less than 3 times a week in the 3 months before random enrollment.

3. Patients with a serum phosphorus level between 1.97 to 3.23 mmol/L (excluding the boundary value) after washout.

4. Kt/Vurea =1.2 or URR =65%.

5. Before the screening period, CKD-MBD related drug treatment is stable for more than one month, including the use of vitamin D (active vitamin D, vitamin D analogues, etc.) or calcimimetics (cinacalcet, etc.) and the dose remains unchanged.

6. The expected survival is greater than 6 months.

7. Willing to give written informed consent.

Exclusion Criteria:

1. Patients with a serum ferritin level =800 ng/mL or TSAT =50%.

2. Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with paroxysmal sleep hemoglobinuria.

3. Patients who received blood transfusions within 3 months prior to Screening, or patients with hemoglobin =60 g/L.

4. Patients with intact-PTH >1000 pg/mL

5. Patients complicated with any of the following gastrointestinal diseases: acute peptic ulcer, chronic ulcerative colitis, localized enteritis, intestinal obstruction, habitual constipation (number of stools once per week), and chronic diarrhea (number of stools four times per day), or patients with a history of gastrectomy or enterectomy or patients who had undergone gastrointestinal surgery within 3 months prior to Screening, or patients with dysphagia.

6. 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.

7. Patients with a history of parathyroidectomy (PTx) or percutaneous anhydrous ethanol injection (PEIT) within 6 months.

8. Patients with uncontrolled diabetes or uncontrolled high blood pressure or current active infectious diseases such as active viral hepatitis.

9. Patients with a history of severe allergies may be allergic to research drugs.

10. Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification) requiring hospitalization within 6 months prior to Screening, or patients who use antiarrhythmic drugs to control arrhythmias or who use antiepileptic drugs to control seizures.

11. Patients who plan to receive a kidney transplant during the study period.

12. Patients with a history of drug and alcohol abuse

13. Patients with active or advanced malignancy.

14. Women who are pregnant or lactating

15. Patients complicated with active bleeding or requiring anticoagulation therapy with citrate in hemodialysis

16. Patients who had participated in other clinical studies within 1 month prior to Screening.

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ferric citrate tablet
250mg/tablet, manufactured by Sinomune Pharmaceutical
• Sevelamer carbonate tablet
800 mg/tablet, manufactured by Genzyme Ireland Limited

Locations

Country	Name	City	State
China	The first affiliated hospital of Baotou medical college	Baotou
China	Beijing Tongren Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha
China	Xiangya Hospital Central South University	Changsha
China	The second hospital of Dalian medical university	Dalian
China	The affiliated hospital of Inner Mongolia Medical University	Hohhot
China	The second people's hospital of Huaian	Huai'an
China	Jinan central hospital	Jinan
China	Shandong province Qianfoshan hospital	Jinan
China	Zhongnan Hospital Southeast University	Nanjing
China	The people's hospital of Guangxi Zhuang Autonomous Region	Nanning
China	Shenzhen people's hospital	Shenzhen
China	The third hospital of Hebei medical university	Shijiazhuang
China	General Hospital of Tianjin Medical University	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Henan provincal people's hospital	Zhengzhou
China	Zhengzhou People's Hospital	Zhengzhou
China	Zhuzhou Central Hospital	Zhuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sinomune 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 as compared to baseline (before the first dose).	12 Weeks
Secondary	Changes in serum phosphorus levels	Changes in serum phosphorus levels from baseline	week 2, 4, 6, 8
Secondary	Area under the curve of serum phosphorus level	Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)	week 0, 2, 4, 6, 8, 12
Secondary	The proportion of subjects whose serum phosphorus levels reached the target	The proportion of subjects whose serum phosphorus levels reached the target range at week 4, 6, 8 and 12 of treatment (the standard was defined as blood phosphorus =1.78mmol /L, and =1.13mmol /L).	week 4, 6, 8 and 12
Secondary	The change in serum calcium (corrected) levels.	The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline.	week 4, 8 and 12
Secondary	The change in the level of intact-PTH levels.	The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline.	week 4, 8 and 12