HyperphosphatemiaPhase 3NCT04456803
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
A Phase 3 study testing Ferric citrate tablet and Sevelamer carbonate tablet in people with Hyperphosphatemia and End Stage Renal Disease, run by Sinomune Pharmaceutical Co., Ltd at 20 sites in China.
Trial 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 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 tablet and Sevelamer carbonate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 20 sitesChina
- Study dates
- 24 May 2019to 13 Sep 2022
- 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
- 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%.
- 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.
- The expected survival is greater than 6 months.
- Willing to give written informed consent.
Who cannot join
- 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
- 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.
- 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.
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- Patients with a history of parathyroidectomy (PTx) or percutaneous anhydrous ethanol injection (PEIT) within 6 months.
- Patients with uncontrolled diabetes or uncontrolled high blood pressure or current active infectious diseases such as active viral hepatitis.
- Patients with a history of severe allergies may be allergic to research drugs.
- 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 who plan to receive a kidney transplant during the study period.
- Patients with a history of drug and alcohol abuse
- Patients with active or advanced malignancy.
- Women who are pregnant or lactating
- Patients complicated with active bleeding or requiring anticoagulation therapy with citrate in hemodialysis
- Patients who had participated in other clinical studies within 1 month prior to Screening.
- Patients who are not suitable for participating in the trial according to the investigator's judgment
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
The first affiliated hospital of Baotou medical college
Baotou
Beijing Tongren Hospital
Beijing
Peking Union Medical College Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
Xiangya Hospital Central South University
Changsha
The second hospital of Dalian medical university
Dalian
The affiliated hospital of Inner Mongolia Medical University
Hohhot
The second people's hospital of Huaian
Huai'an
Jinan central hospital
Jinan
Shandong province Qianfoshan hospital
Jinan
Zhongnan Hospital Southeast University
Nanjing
The people's hospital of Guangxi Zhuang Autonomous Region
Nanning
Shenzhen people's hospital
Shenzhen
The third hospital of Hebei medical university
Shijiazhuang
General Hospital of Tianjin Medical University
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan provincal people's hospital
Zhengzhou
Zhengzhou People's Hospital
Zhengzhou
Zhuzhou Central Hospital
Zhuzhou
About this study
Official title: A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
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.
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- Being tested
- Ferric citrate tablet, Sevelamer carbonate tablet
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric citrate tabletDrug
250mg/tablet, manufactured by Sinomune Pharmaceutical
Sevelamer carbonate tabletDrug
Also called Renvela
800 mg/tablet, manufactured by Genzyme Ireland Limited
| Study group | Role | What they receive |
|---|---|---|
| Ferric citrate tablet | Experimental | Ferric citrate arm will receive ferric citrate tablets three times a day with each meal. Receives: Drug: Ferric citrate tablet |
| Sevelamer carbonate tablet | Active comparator | Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal. Receives: Drug: Sevelamer carbonate tablet |
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 as compared to baseline (before the first dose).
Measured: 12 Weeks
Secondary outcomes (5)
Changes in serum phosphorus levels
Changes in serum phosphorus levels from baseline
Measured: week 2, 4, 6, 8
Area under the curve of serum phosphorus level
Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)
Measured: week 0, 2, 4, 6, 8, 12
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).
Measured: week 4, 6, 8 and 12
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.
Measured: week 4, 8 and 12
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.
Measured: week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start24 May 2019
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinomune Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456803
- Sponsor's protocol ID
- CTS-CO-1642
- Other IDs
- CTR20190978
- Status last verified
- Apr 2024
- First submitted
- 30 Jun 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT04456803
- Acronym / sponsor ID
- CTS-CO-1642
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Sinomune Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric citrate tablet | Experimental | Drug: Ferric citrate tabletFerric citrate arm will receive ferric citrate tablets three times a day with each meal. |
| Sevelamer carbonate tablet | Active comparator | Drug: Sevelamer carbonate tabletSevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
- 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.
Key exclusion criteria (17 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric citrate tablet250mg/tablet, manufactured by Sinomune Pharmaceutical | Drug | Ferric citrate tablet |
| Sevelamer carbonate tabletAlso: Renvela800 mg/tablet, manufactured by Genzyme Ireland Limited | Drug | Sevelamer carbonate tablet |
Primary outcome
The change in serum phosphorus levels
Time frame: 12 Weeks
The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).
5 secondary outcomes
Changes in serum phosphorus levels
Time frame: week 2, 4, 6, 8
Area under the curve of serum phosphorus level
Time frame: week 0, 2, 4, 6, 8, 12
The proportion of subjects whose serum phosphorus levels reached the target
Time frame: week 4, 6, 8 and 12
The change in serum calcium (corrected) levels.
Time frame: week 4, 8 and 12
The change in the level of intact-PTH levels.
Time frame: week 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric citrate tablet and Sevelamer carbonate tablet in people with Hyperphosphatemia and End Stage Renal Disease, run by Sinomune Pharmaceutical Co., Ltd at 20 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 7 inclusion and 17 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
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 17 Apr 2024.