Completed

Ferric Citrate Tablets for Hyperphosphatemia in Chronic Kidney Disease Patients on Hemodialysis

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Study Aim

This phase 3 study aims to evaluate how effectively Ferric Citrate Tablets can manage high phosphorus levels in the blood of individuals with Chronic Kidney Disease who are on hemodialysis, by comparing the change in serum phosphorus levels at the end of treatment to the levels before the first dose.

What is being tested

Ferric citrate tablet

+ Sevelamer carbonate tablet

Drug
Who is being recruted

Urogenital Diseases+14

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 75 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2019
See protocol details

Summary

Principal SponsorSinomune Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 24, 2019

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of Ferric Citrate Tablets in treating high phosphorus levels, or hyperphosphatemia, in patients with Chronic Kidney Disease who are undergoing hemodialysis. The importance of this study lies in finding a potential new treatment option for managing hyperphosphatemia, a common complication in patients with kidney disease. This could significantly improve patient care and quality of life. The study is designed as a multicenter, randomized, open-label, parallel, phase III study. It involves a Screening/Washout period of 14 days and a Treatment/Observation period of 12 weeks. Patients who regularly undergo hemodialysis must stop using their current phosphorus binder before the Washout period. During the Treatment period, participants will be randomly assigned to either the Ferric Citrate Tablets group or the Sevelamer Carbonate Tablet group. The main goal is to measure the change in serum phosphorus levels at the end of the treatment compared to the beginning, to determine the effectiveness of the Ferric Citrate Tablets.

Official TitleA Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
NCT04456803
Principal SponsorSinomune Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

239 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPhosphorus Metabolism DisordersPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesHyperphosphatemia

Criteria

7 inclusion criteria required to participate
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%.
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17 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 20 locations

Suspended

The first affiliated hospital of Baotou medical college

Baotou, ChinaOpen The first affiliated hospital of Baotou medical college in Google Maps
Suspended

Beijing Tongren Hospital

Beijing, China
Suspended

Peking Union Medical College Hospital

Beijing, China
Suspended

The Second Xiangya Hospital of Central South University

Changsha, China
Completed20 Study Centers