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

NCT ID: NCT04456803

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2022-09-13

Brief 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.

Detailed 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.

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 tablet

Ferric citrate arm will receive ferric citrate tablets three times a day with each meal.

Group Type: EXPERIMENTAL

Ferric citrate tablet

Intervention Type: DRUG

250mg/tablet, manufactured by Sinomune Pharmaceutical

Sevelamer carbonate tablet

Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal.

Group Type: ACTIVE_COMPARATOR

Sevelamer carbonate tablet

Intervention Type: DRUG

800 mg/tablet, manufactured by Genzyme Ireland Limited

Interventions

Ferric citrate tablet

250mg/tablet, manufactured by Sinomune Pharmaceutical

Intervention Type: DRUG

Sevelamer carbonate tablet

800 mg/tablet, manufactured by Genzyme Ireland Limited

Intervention Type: DRUG

Other Intervention Names

Renvela

Eligibility Criteria

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

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

Sponsors

Sinomune Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , China

Countries

China

Other Identifiers

CTR20190978

Identifier Type: OTHER

Identifier Source: secondary_id

CTS-CO-1642

Identifier Type: -

Identifier Source: org_study_id