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

Sponsor

Sinomune Pharmaceutical Co., Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04456803

Collaborator

(none)

240

Enrollment

Locations

Arms

25.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia End Stage Renal Disease ESRD	Drug: Ferric citrate tablet Drug: Sevelamer carbonate tablet	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 24, 2019

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferric citrate tablet Ferric citrate arm will receive ferric citrate tablets three times a day with each meal.	Drug: Ferric citrate tablet 250mg/tablet, manufactured by Sinomune Pharmaceutical
Active Comparator: Sevelamer carbonate tablet Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal.	Drug: Sevelamer carbonate tablet 800 mg/tablet, manufactured by Genzyme Ireland Limited Other Names: Renvela

Arm

Intervention/Treatment

Experimental: Ferric citrate tablet

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

Drug: Ferric citrate tablet

250mg/tablet, manufactured by Sinomune Pharmaceutical

Active Comparator: Sevelamer carbonate tablet

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

Drug: Sevelamer carbonate tablet

800 mg/tablet, manufactured by Genzyme Ireland Limited

Other Names:

Renvela

Outcome Measures

Primary Outcome Measures

The change in serum phosphorus levels [12 Weeks]
The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).

Secondary Outcome Measures

Changes in serum phosphorus levels [week 2, 4, 6, 8]
Changes in serum phosphorus levels from baseline
Area under the curve of serum phosphorus level [week 0, 2, 4, 6, 8, 12]
Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)
The proportion of subjects whose serum phosphorus levels reached the target [week 4, 6, 8 and 12]
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).
The change in serum calcium (corrected) levels. [week 4, 8 and 12]
The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline.
The change in the level of intact-PTH levels. [week 4, 8 and 12]
The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between the age of 18 and 75 years (including the boundary value) and no gender limitation;
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.
Patients with a serum phosphorus level between 1.97 to 3.23 mmol/L (excluding the boundary value) after washout.
Kt/Vurea ≥1.2 or URR ≥65%.
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.
The expected survival is greater than 6 months.
Willing to give written informed consent.

Exclusion Criteria:

Patients with a serum ferritin level ≥800 ng/mL or TSAT ≥50%.
Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with paroxysmal sleep hemoglobinuria.
Patients who received blood transfusions within 3 months prior to Screening, or patients with hemoglobin ≤60 g/L.
Patients with intact-PTH >1000 pg/mL
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.
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 a history of parathyroidectomy (PTx) or percutaneous anhydrous ethanol injection (PEIT) within 6 months.
Patients with uncontrolled diabetes or uncontrolled high blood pressure or current active infectious diseases such as active viral hepatitis.
Patients with a history of severe allergies may be allergic to research drugs.
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.
Patients who plan to receive a kidney transplant during the study period.
Patients with a history of drug and alcohol abuse
Patients with active or advanced malignancy.
Women who are pregnant or lactating
Patients complicated with active bleeding or requiring anticoagulation therapy with citrate in hemodialysis
Patients who had participated in other clinical studies within 1 month prior to Screening.
Patients who are not suitable for participating in the trial according to the investigator's judgment

Contacts and Locations

Locations

	Site	City	Country
1	The first affiliated hospital of Baotou medical college	Baotou	China
2	Beijing Tongren Hospital	Beijing	China
3	Peking Union Medical College Hospital	Beijing	China
4	The Second Xiangya Hospital of Central South University	Changsha	China
5	Xiangya Hospital Central South University	Changsha	China
6	The second hospital of Dalian medical university	Dalian	China
7	The affiliated hospital of Inner Mongolia Medical University	Hohhot	China
8	The second people's hospital of Huaian	Huai'an	China
9	Jinan central hospital	Jinan	China
10	Shandong province Qianfoshan hospital	Jinan	China
11	Zhongnan Hospital Southeast University	Nanjing	China
12	The people's hospital of Guangxi Zhuang Autonomous Region	Nanning	China
13	Shenzhen people's hospital	Shenzhen	China
14	The third hospital of Hebei medical university	Shijiazhuang	China
15	General Hospital of Tianjin Medical University	Tianjin	China
16	First Affiliated Hospital of Zhengzhou University	Zhengzhou	China
17	Henan provincal people's hospital	Zhengzhou	China
18	Zhengzhou People's Hospital	Zhengzhou	China
19	Zhuzhou Central Hospital	Zhuzhou	China
20	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	China