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HyperphosphatemiaPhase 3NCT03984760

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

A Phase 3 study testing Ferric Citrate and Sevelamer Carbonate in people with Hyperphosphatemia and End Stage Renal Disease, run by Panion & BF Biotech Inc. at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hyperphosphatemia, End Stage Renal Disease, ESRD
What is being tested?
Ferric Citrate and Sevelamer Carbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
24 sitesChina
Study dates
19 Jun 2019to 20 Feb 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to give written informed consent.;
  • Between the age of 18 and 75 years (including the boundary value);
  • Patients who maintain the hemodialysis schedule as 3 times a week and the dialysis schedule should remain unchanged during the study period;
  • At Screening, patients who have received phosphate binder for at least 4 weeks and have a serum phosphorus level between 2.5 and 8.0 mg/dL (0.81 to 2.58 mmol/L) (excluding the boundary value) after treatment;
  • Patients with a serum phosphorus level between 5.5 and 10.0 mg/dL (1.78 to 3.23 mmol/L) (excluding the boundary value) after washout.

Who cannot join

  • Patients with severe gastrointestinal diseases (such as acute peptic ulcer, chronic ulcerative colitis, regional enteritis, ileus) or patients with dysphagia;
  • Patients with a history of gastrectomy or enterectomy (excluding endoscopic excision or caecectomy) or patients who had undergone gastrointestinal surgery within 3 months prior to Screening;
  • Patients with severe constipation (times of bowel movement≤ 1 time/week), chronic diarrhea (times of bowel movement≥ 4 times/day), severe gastrointestinal motility disorder;
  • Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with a serum ferritin level >800 ng/mL or TSAT >50% at Screening;
  • Patients with a serum calcium level (corrected) <8.0 mg/dL (2.0 mmol/L) or >11.0 mg/dL (2.75 mmol/L) after washout;
  • Patients with intact-PTH>800pg/mL at Screening, or patients undergone parathyroid surgery within 6 months prior to Screening or requiring parathyroid surgery;
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  • Patients who received blood transfusions for treating anemia within 3 months prior to Screening;
  • Patients who require phosphorus-binding agents containing aluminum, magnesium, calcium and lanthanum in addition to the study drug or patients who require an antacid with a phosphorus binding effect during the study period;
  • Patients who require citrate preparation as an anticoagulant during hemodialysis treatment during the study period;
  • 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 cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification, acute myocardial infarction, unstable angina, etc.) requiring hospitalization within 6 months prior to Screening;
  • Patients who are known to be intolerant to sevelamer carbonate tablet;
  • Patients with a history of allergies to iron preparations or those who are intolerant to iron preparations;
  • Patients who are scheduled to have a kidney transplant during the study period;
  • Patients with a current or past history of malignancy within 5 years prior to Screening;
  • Women who are pregnant or lactating, or patients who are unable to take effective contraception from screening to 6 months after discontinuation (including male subjects and their female spouses);
  • Patients who had participated in other clinical studies and other received investigational drug product within 1 month or 5 half-lives of the drug product (whichever is longer) prior to Screening;
  • Patients who are not suitable for participating in the trial according to the investigator's judgment;
  • Patients who are unwilling or unable to follow the protocol process.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Baotou Central Hospital

    Baotou

  • The General Hospital of the People's Liberation Army (PLAGH)

    Beijing

  • The Second Hospital of Jilin University

    Changchun

  • Daping Hospital

    Chongqing

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The First Affiliated Hospital/School Of Clinical Medicine of Guangdong Pharmaceutical University

    Guangzhou

  • Jilin Guowen Hospital

    Jilin City

  • Jiujiang University Affiliated Hospital

    Jiujiang

  • Meihekou Central Hospital

    Meihekou

  • Jiangxi Provincial People's Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • BenQ Medical Center

    Nanjing

  • JiangSu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

    Nanjing

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Changhai Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • Tonghua Central Hospital

    Tonghua

  • Fifth Hospital in Wuhan

    Wuhan

  • Renmin Hospital of Wuhan University

    Wuhan

  • Zhongnan Hospital of Wuhan University

    Wuhan

  • Henan Provincial People's Hospital

    Zhengzhou

  • Affiliated Hospital of Zunyi Medical University

    Zunyi

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Study to Assess the Efficacy and Safety of Ferric Citrate Capsules for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis

Read the detailed description

This is a multicenter, randomized, open-label, active-controlled, parallel, phase III study which aims to assess the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). During the Treatment period, the subjects will be randomly assigned to the ferric citrate capsule group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.

Being tested
Ferric Citrate, Sevelamer Carbonate
Keywords
Kidney Diseases, Kidney Failure, Chronic, Hyperphosphatemia, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorder
Medical subject headings
Hyperphosphatemia, Kidney Failure, Chronic, Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric CitrateDrug

    Take the capsules with meals or immediately after meals.

  • Sevelamer CarbonateDrug

    Take the tablets with meals.

Study groups in NCT03984760
Study groupRoleWhat they receive
Ferric Citrate CapsuleExperimentalFerric Citrate Capsule, product specification: 500 mg/cap, manufactured by Panion \& BF Biotech Inc.
Receives: Drug: Ferric Citrate
Sevelamer Carbonate TabletActive comparatorSevelamer carbonate tablet group, product specification: 800 mg/tablet, manufactured by Genzyme Ireland Limited
Receives: Drug: Sevelamer Carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in serum phosphorus levels

    The change in serum phosphorus levels at the end of treatment (Visit 10 or ET) as compared to baseline (before the first dose).

    Measured: 12 Weeks

Secondary outcomes (6)

  1. Serum phosphorus levels

    Serum phosphorus levels at the end of treatment;

    Measured: 12 Weeks

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

    The proportion of subjects whose serum phosphorus levels reached the target range (3.5 to 5.5 mg/dL, 1.13 to 1.78 mmol/L) at the end of the treatment;

    Measured: 12 Weeks

  3. The response rate of serum phosphorus

    The response rate of serum phosphorus at the end of treatment (defined as reduction of the serum phosphorus level exceeds 25% as compared to baseline);

    Measured: 12 Weeks

  4. The change in serum calcium (corrected) levels

    The change in serum calcium (corrected) levels at the end of treatment as compared to baseline;

    Measured: 12 Weeks

  5. The change in the [Ca] × [P] product relative

    The change in the [Ca] × [P] product relative at the end of treatment as compared to baseline;

    Measured: 12 Weeks

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

    The change in the level of intact-PTH levels at the end of treatment as compared to baseline.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2019
  2. Study start19 Jun 2019
  3. Primary completion20 Feb 2021
  4. Study completion20 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03984760
Sponsor's protocol ID
WG-PBB00302
Status last verified
Mar 2021
First submitted
5 Jun 2019
Last updated
10 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PubMed 40576086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferric Citrate and Sevelamer Carbonate in people with Hyperphosphatemia and End Stage Renal Disease, run by Panion & BF Biotech Inc. at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in serum phosphorus levels (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03984760, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.

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