Clinical trial NCT04456803: Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
End Stage Renal Disease
ESRD
Lead sponsor: Sinomune Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in serum phosphorus levels
timeFrame: 12 Weeks
Secondary outcomes:
measure: Changes in serum phosphorus levels
timeFrame: week 2, 4, 6, 8
measure: Area under the curve of serum phosphorus level
timeFrame: week 0, 2, 4, 6, 8, 12
measure: The proportion of subjects whose serum phosphorus levels reached the target
timeFrame: week 4, 6, 8 and 12
measure: The change in serum calcium (corrected) levels.
timeFrame: week 4, 8 and 12
measure: The change in the level of intact-PTH levels.
timeFrame: week 4, 8 and 12
Other outcomes:
Locations:
city: Baotou
country: China
facility: The first affiliated hospital of Baotou medical college
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Dalian
country: China
facility: The second hospital of Dalian medical university
city: Hohhot
country: China
facility: The affiliated hospital of Inner Mongolia Medical University
city: Huai'an
country: China
facility: The second people's hospital of Huaian
city: Jinan
country: China
facility: Jinan central hospital
city: Jinan
country: China
facility: Shandong province Qianfoshan hospital
city: Nanjing
country: China
facility: Zhongnan Hospital Southeast University
city: Nanning
country: China
facility: The people's hospital of Guangxi Zhuang Autonomous Region
city: Shenzhen
country: China
facility: Shenzhen people's hospital
city: Shijiazhuang
country: China
facility: The third hospital of Hebei medical university
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan provincal people's hospital
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
Study officials:
References: