Completed

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

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What is being tested

Ferric citrate tablet

+ Sevelamer carbonate tablet
Drug
Who is being recruted

Hyperphosphatemia

+ End Stage Renal Disease
+ ESRD
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, 2019Actual date on which the first participant was enrolled.

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. 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.

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 
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hyperphosphatemia
End Stage Renal Disease
ESRD
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

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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

The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).
Secondary Objectives

Changes in serum phosphorus levels from baseline

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 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 at week 4, 8 and 12 of treatment as compared to baseline.

The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline.

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 collegeBaotou, ChinaSee the location
Suspended
Beijing Tongren HospitalBeijing, China
Suspended
Peking Union Medical College HospitalBeijing, China
Suspended
The Second Xiangya Hospital of Central South UniversityChangsha, China
Completed20 Study Centers