Chronic Kidney DiseasePhase 3NCT00681941
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
A Phase 3 study testing Sevelamer carbonate (Renvela®) in people with Chronic Kidney Disease and Hyperphosphatemia, run by Genzyme, a Sanofi Company at 25 sites in 5 countries.
Trial summary
Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hyperphosphatemia
- What is being tested?
- Sevelamer carbonate (Renvela®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 25 sitesin 5 countries
- Study dates
- Jan 2006to Mar 2007
- 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
- A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.
- Men or woman 18 years of age or older
- If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period
- Willing to avoid any intentional changes in diet such as fasting or dieting
- Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
- At Screening (Visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin D ≥ 10 ng/mL 2. iPTH ≤ 800 pg/mL
Show all 15Show fewer
- Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study
- Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
- Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
- If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs
- Expecting not to initiate dialysis for the duration of this study
- Considered compliant with phosphate binders (if applicable)
- Willing and able to provide informed consent
- Has not participated in any other investigational drug studies within 30 days prior to enrollment,
- Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
Who cannot join
- Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders
- Active ethanol or drug abuse, excluding tobacco use
- Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
- Pregnant or breast-feeding
- Evidence of active malignancy except for basal cell carcinoma of the skin
Show all 9Show fewer
- Unable to comply with the requirements of the study
- Known hypersensitivity to sevelamer or any constituents of the study drug
- Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United Kingdom9 sites
Birmingham Hospital, Queen Elizabeth Medical Centre
Birmingham, England, B15 2PR
Southmead Hospital
Bristol, England, BS10 5NB
Addenbrooke's Dialysis Centre
Cambridge, England, CB2 2QQ
Leicester General Hospital
Leicester, England, LE5 4PW
Renal Department, The Royal London Hospital
London, England, E1 1BB
Renal & Urology SDU Offices
London, England, SE1 9RT
Renal Dialysis Unit, Manchester Royal Infirmary
Manchester, England, M13 9WL
Department of Renal Medicine, Hope Hospital
Manchester, England, M6 8HD
Renal Unit, Queen Alexandra Hospital
Portsmouth, England, PO6 3RY
Germany6 sites
Universitätsklinikum Aachen, Medizinsche Klinik II
Aachen, D-52074
Universitätsklinikum Hamburg Eppendorf
Hamburg, D-20246
Heimdialysezentrum
Heidelberg, D-69115
KfH Nierenzentrum
Nuremberg, D-90431
Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin
Solingen, D 42653
Nephrologisches Zentrum
Villingen-Schwenningen, D 78054
Australia5 sites
Renal Research Unit, Launceston General Hospital
Launceston, Tasmania, 7250
The Royal Melbourne Hospital, Department of Nephrology
Parkville, Victoria, 3050
Melbourne Renal Research Group, Epworth Medical Centre
Richmond, Victoria, 3121
Renal Unit, The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Nephrology Department, Princess Alexandra Hospital
Wooloongabba, Queensland, 4102
Denmark4 sites
Nyremedicinsk Afdeling, Medicinerhuset
Aalborg, DK-9100
Medicinsk Afdeling
Copenhagen, DK-2100
Nefrologisk Afdeling, Hilleroed Sygehus
Hilleroed, DK 3400
Medicinsk Afdeling, nefrologisk, Roskilde Sygehus
Roskilde, DK-4000
About this study
Official title: An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.
- Conditions
- Chronic Kidney Disease, Hyperphosphatemia
- Being tested
- Sevelamer carbonate (Renvela®)
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer carbonate (Renvela®)Drug
Sevelamer Carbonate Tablets Dosed Three Times A Day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sevelamer Carbonate Tablets Dosed Three Times A Day Receives: Drug: Sevelamer carbonate (Renvela®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels
Measured: Up to day 70
Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.
Measured: Up to day 70
Secondary outcomes (3)
Serum calcium-phosphorus product
Measured: Up to day 70
Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]
Measured: Up to day 70
Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET
Measured: Up to day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionMar 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681941
- Sponsor's protocol ID
- SVCARB00105
- Other IDs
- ACTRN012606000380594
- Status last verified
- Mar 2015
- First submitted
- 19 May 2008
- Last updated
- 20 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
- ClinicalTrials.gov ID
- NCT00681941
- Acronym / sponsor ID
- SVCARB00105
- Conditions
- Chronic Kidney Disease, Hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 May 2008 (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.
Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sevelamer carbonate (Renvela®)Sevelamer Carbonate Tablets Dosed Three Times A Day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.
- Men or woman 18 years of age or older
- If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period
- Willing to avoid any intentional changes in diet such as fasting or dieting
- Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
Key exclusion criteria (9 listed)
- Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders
- Active ethanol or drug abuse, excluding tobacco use
- Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
- Pregnant or breast-feeding
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 carbonate (Renvela®)Sevelamer Carbonate Tablets Dosed Three Times A Day | Drug | 1 |
Primary outcome
Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels
Time frame: Up to day 70
Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals.
Time frame: Up to day 70
3 secondary outcomes
Serum calcium-phosphorus product
Time frame: Up to day 70
Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol]
Time frame: Up to day 70
Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET
Time frame: Up to day 70
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 20 Mar 2015.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevelamer carbonate (Renvela®) in people with Chronic Kidney Disease and Hyperphosphatemia, run by Genzyme, a Sanofi Company at 25 sites in 5 countries.
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 15 inclusion and 9 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 20 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 25 sites in United Kingdom, Germany, Australia, Denmark, France. 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?
Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels (time frame: Up to day 70). 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 20 Mar 2015.