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CompletedNCT04456803Updated Apr 17, 2024

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

A Phase 3 interventional study of Ferric citrate tablet and Sevelamer carbonate tablet in Hyperphosphatemia, End Stage Renal Disease and ESRD, sponsored by Sinomune Pharmaceutical Co., Ltd. Completed at 20 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Sinomune Pharmaceutical Co., Ltd · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled May 2019, registered Jun 2020).
Phase
Phase 3
Study type
Interventional
Enrollment
239
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperphosphatemia
  • End Stage Renal Disease
  • ESRD
03

In context

Hyperphosphatemia

173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.

This study's enrollment of 239 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Sinomune Pharmaceutical Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 ≤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 , or alanine aminotransferase ≥ 2 times the ) 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 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 .
  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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
239 participants (actual)

Study arms

  • Experimental
    Ferric citrate tablet

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

    Drug: Ferric citrate tablet

  • Active comparator
    Sevelamer carbonate tablet

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

    Drug: Sevelamer carbonate tablet

Interventions

06

What researchers measure

Primary outcomes

  1. The change in serum phosphorus levels

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

    Time frame: 12 Weeks

Secondary outcomes

  1. Changes in serum phosphorus levels

    Changes in serum phosphorus levels from baseline

    Time frame: week 2, 4, 6, 8

  2. Area under the curve of serum phosphorus level

    Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)

    Time frame: week 0, 2, 4, 6, 8, 12

  3. The proportion of subjects whose serum phosphorus levels reached the target

    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).

    Time frame: week 4, 6, 8 and 12

  4. The change in serum calcium (corrected) levels.

    The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline.

    Time frame: week 4, 8 and 12

  5. The change in the level of intact-PTH levels.

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

    Time frame: week 4, 8 and 12

07

Study locations

20 sites
  • The first affiliated hospital of Baotou medical college
    Baotou, China
  • Beijing Tongren Hospital
    Beijing, China
  • Peking Union Medical College Hospital
    Beijing, China
  • The Second Xiangya Hospital of Central South University
    Changsha, China
  • Xiangya Hospital Central South University
    Changsha, China
  • The second hospital of Dalian medical university
    Dalian, China
  • The affiliated hospital of Inner Mongolia Medical University
    Hohhot, China
  • The second people's hospital of Huaian
    Huai'an, China
  • Jinan central hospital
    Jinan, China
  • Shandong province Qianfoshan hospital
    Jinan, China
  • Zhongnan Hospital Southeast University
    Nanjing, China
  • The people's hospital of Guangxi Zhuang Autonomous Region
    Nanning, China
  • Shenzhen people's hospital
    Shenzhen, China
  • The third hospital of Hebei medical university
    Shijiazhuang, China
  • General Hospital of Tianjin Medical University
    Tianjin, China
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, China
  • Henan provincal people's hospital
    Zhengzhou, China
  • Zhengzhou People's Hospital
    Zhengzhou, China
  • Zhuzhou Central Hospital
    Zhuzhou, China
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2019 to primary completion in Sep 2022, 39 months.

Of 21 phase 3 interventional studies under Hyperphosphatemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 22. This study's 39 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2020
First posted
Jul 7, 2020
StartActual
May 24, 2019
Primary completionActual
Sep 13, 2022
CompletionActual
Sep 13, 2022
Last update
Apr 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04456803
Lead sponsor
Sinomune Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
May 24, 2019
Primary completion
Sep 13, 2022
Completion
Sep 13, 2022
Last update
Apr 17, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ferric citrate

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