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

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    Sinomune Pharmaceutical Co., Ltd
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Updated on 5 August 2020
See if I qualify
vitamins
renal disease
chronic kidney disease
sevelamer
vitamin d
serum phosphorus measurement
active vitamin d
chronic disease
nephropathy
cinacalcet
hyperphosphatemia
hemoperfusion
hemofiltration
bone disorder
carbonate
serum phosphorus level

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, openlabel, 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.

Details
Condition Chronic renal failure, Hyperphosphatemia
Age 18years - 75years
Treatment Ferric citrate tablet, Sevelamer carbonate tablet
Clinical Study IdentifierNCT04456803
SponsorSinomune Pharmaceutical Co., Ltd
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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 intactPTH 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
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vitamins
renal disease
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sevelamer
vitamin d
serum phosphorus measurement
active vitamin d
chronic disease
nephropathy
cinacalcet
hyperphosphatemia
hemoperfusion
hemofiltration
bone disorder
carbonate
serum phosphorus level

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