HemodialysisPhase 4NCT01755078
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
A Phase 4 study testing Sevelamer HCl and Calcium-based phosphate binder in people with Hemodialysis and Hyperphosphatemia, run by Chugai Pharma Taiwan.
Trial summary
The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemodialysis, Hyperphosphatemia, Cardiovascular Events
- What is being tested?
- Sevelamer HCl and Calcium-based phosphate binder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jun 2009
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged between 18-70 years old
- Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
- On stable TIW hemodialysis for 3 months or longer
Who cannot join
- Patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)
- Any of the following abnormalities: ALT or AST > 3X ULN; iPTH > 1000 or < 150 pg/mL
- History of dysphagia or swallowing disorders
- History of GI motility disorder or GI bleeding within 3 months prior to entry
About this study
The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.
- Conditions
- Hemodialysis, Hyperphosphatemia, Cardiovascular Events
- Being tested
- Sevelamer HCl, Calcium-based phosphate binder
- Keywords
- Phosphate binder
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer HClDrug
Also called Renagel Tablets
Non-metal phosphate binder
Calcium-based phosphate binderDrug
Also called Calcium carbonate, Calcium acetate
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer HCl | Experimental | Sevelamer HCl regular treatment 1-3 tablets TID Receives: Drug: Sevelamer HCl |
| Calcium-based binder | Active comparator | Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID Receives: Drug: Calcium-based phosphate binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
Measured: 12 months
Secondary outcomes (7)
Change from baseline, Ca, P, Ca*P
Measured: 12 months
Change from baseline, lipid profile
Measured: 12 months
Change from baseline, CRP
Measured: 12 months
Change from baseline, iPTH (stragified)
Measured: 12 months
Change from baseline, homocysteine, folate and Vit B12
Measured: 12 months
CV-related event rate (OPD admission and hospitalization)
Measured: 12 months
Comparison of medical-related expenses between group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharma Taiwan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chiu-Ching Huang, Professor, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755078
- Sponsor's protocol ID
- CPT-REN-002
- Status last verified
- Dec 2012
- First submitted
- 19 Dec 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- 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 40576086Lin HH, Liou HH, Wu MS, Huang CC. Factors associated with serum fetuin-A concentrations after long-term use of different phosphate binders in hemodialysis patients. BMC Nephrol. 2016 Mar 23;17:33. doi: 10.1186/s12882-016-0245-3.
PubMed 27007989
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01755078
- Acronym / sponsor ID
- CPT-REN-002
- Conditions
- Hemodialysis, Hyperphosphatemia, Cardiovascular Events
- Keywords
- Phosphate binder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Chugai Pharma TaiwanIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Dec 2012 (estimated)
- 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.
The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer HCl | Experimental | Drug: Sevelamer HClSevelamer HCl regular treatment 1-3 tablets TID |
| Calcium-based binder | Active comparator | Drug: Calcium-based phosphate binderCalcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged between 18-70 years old
- Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
- On stable TIW hemodialysis for 3 months or longer
Key exclusion criteria (4 listed)
- Patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)
- Any of the following abnormalities: ALT or AST > 3X ULN; iPTH > 1000 or < 150 pg/mL
- History of dysphagia or swallowing disorders
- History of GI motility disorder or GI bleeding within 3 months prior to entry
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 |
|---|---|---|
| Sevelamer HClAlso: Renagel TabletsNon-metal phosphate binder | Drug | Sevelamer HCl |
| Calcium-based phosphate binderAlso: Calcium carbonate, Calcium acetate | Drug | Calcium-based binder |
Primary outcome
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
Time frame: 12 months
7 secondary outcomes
Change from baseline, Ca, P, Ca*P
Time frame: 12 months
Change from baseline, lipid profile
Time frame: 12 months
Change from baseline, CRP
Time frame: 12 months
Change from baseline, iPTH (stragified)
Time frame: 12 months
Change from baseline, homocysteine, folate and Vit B12
Time frame: 12 months
CV-related event rate (OPD admission and hospitalization)
Time frame: 12 months
Comparison of medical-related expenses between group
Time frame: 12 months
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 5 Aug 2014.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 27007989Lin HH, Liou HH, Wu MS, Huang CC. Factors associated with serum fetuin-A concentrations after long-term use of different phosphate binders in hemodialysis patients. BMC Nephrol. 2016 Mar 23;17:33. doi: 10.1186/s12882-016-0245-3.
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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.
Chiu-Ching Huang, Professor principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevelamer HCl and Calcium-based phosphate binder in people with Hemodialysis and Hyperphosphatemia, run by Chugai Pharma Taiwan.
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 3 inclusion and 4 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation (time frame: 12 months). 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 NCT01755078, which also lists 2 linked publications.
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 5 Aug 2014.