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.
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
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
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.
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- 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 group | Role | What they receive |
|---|---|---|
| Ferric Citrate Capsule | Experimental | Ferric Citrate Capsule, product specification: 500 mg/cap, manufactured by Panion \& BF Biotech Inc. Receives: Drug: Ferric Citrate |
| Sevelamer Carbonate Tablet | Active comparator | Sevelamer 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.
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)
Serum phosphorus levels
Serum phosphorus levels at the end of treatment;
Measured: 12 Weeks
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
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
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
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
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.
- First posted13 Jun 2019
- Study start19 Jun 2019
- Primary completion20 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Panion & BF Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Weigao Panion Pharmaceutical Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Xiangmei Chen, Principal investigator, The General Hospital of the People's Liberation Army (PLAGH)
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