Chronic Kidney DiseasePhase 3NCT01736150
Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis
A Phase 3 study testing Sevelamer carbonate in people with Chronic Kidney Disease and Chronic Kidney Disease on Hemodialysis, run by Genzyme, a Sanofi Company at 18 sites in China.
Trial summary
The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Chronic Kidney Disease on Hemodialysis
- What is being tested?
- Sevelamer carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 18 sitesChina
- Study dates
- Mar 2010to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
- Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
- Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a
Who cannot join
- Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
- Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
Sichuan Provincial People's Hospital
Chengdu
West China Hospital
Chengdu
Southwest Hospital
Chongqing
Guangzhou First Municipal People's Hospital
Guangzhou
Nanfang Hospital
Guangzhou
Sun Yat-Sen University School of Medicine 1st Affiliated Hospital
Guangzhou
Zhejiang University School of Medicine 1st Affiliated Hospital
Hangzhou
Jiangsu Province Hospital
Nanjing
Zhongda Hospital of Southeast University
Nanjing
Qingdao Municipal Hospital
Qingdao
Changzheng Hospital
Shanghai
Renji Hospital
Shanghai
Shanghai Ruijin Hospital
Shanghai
Xinhua Hospital
Shanghai
Zhongshan Hospital
Shanghai
Wenzhou College of Medicine 1st Affiliated Hospital
Wenzhou
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis
The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.
- Being tested
- Placebo, Sevelamer carbonate
- Keywords
- Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
- Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals.
- If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.
Sevelamer carbonateDrug
Also called Renvela
- Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals.
- If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer carbonate | Experimental | Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. Receives: Drug: Sevelamer carbonate |
| Placebo | Placebo comparator | Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
Measured: 8 weeks
Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs.
Measured: 11 weeks
Secondary outcomes (1)
Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736150
- Sponsor's protocol ID
- SVCARB03808
- Status last verified
- Mar 2015
- First submitted
- 26 Nov 2012
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT01736150
- Acronym / sponsor ID
- SVCARB03808
- Keywords
- Hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Nov 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 aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer carbonate | Experimental | Drug: Sevelamer carbonateSubjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
- Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
- Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a
Key exclusion criteria (2 listed)
- Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
- Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition
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 |
|---|---|---|
| Placebo* Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals. | Drug | Placebo |
| Sevelamer carbonateAlso: Renvela* Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals. | Drug | Sevelamer carbonate |
Primary outcome
Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
Time frame: 8 weeks
Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs.
Time frame: 11 weeks
1 secondary outcome
Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).
Time frame: 8 weeks
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 23 Mar 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
18 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 Sevelamer carbonate in people with Chronic Kidney Disease and Chronic Kidney Disease on Hemodialysis, run by Genzyme, a Sanofi Company at 18 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 3 inclusion and 2 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. Some participants in this study may receive a placebo. 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?
Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous. (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 23 Mar 2015.