Completed

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

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: April 17, 2024

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 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.

NCT04456803

Principal SponsorSinomune Pharmaceutical Co., Ltd

Last updated: April 17, 2024

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 DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPhosphorus Metabolism DisordersPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesKidney Failure, ChronicHyperphosphatemia

Criteria

7 inclusion criteria required to participate

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.

Willing to give written informed consent.

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%.

Show More Criteria

17 exclusion criteria prevent from participating

Patients with a history of severe allergies may be allergic to research drugs.

Patients who had participated in other clinical studies within 1 month prior to Screening.

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 with a serum ferritin level ≥800 ng/mL or TSAT ≥50%.

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

The first affiliated hospital of Baotou medical college

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

Beijing Tongren Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The Second Xiangya Hospital of Central South University

Changsha, China

Completed20 Study Centers