Renal Failure ChronicPhase 3TOSCANANCT02332811
An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
A Phase 3 study testing sevelamer carbonate 800mg and sevelamer carbonate 2.4 g in people with Renal Failure Chronic, run by Genzyme, a Sanofi Company at 1 site in Russia.
Trial summary
Primary Objective: Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis Secondary Objective: Evaluate the safety on the basis of adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic
- What is being tested?
- sevelamer carbonate 800mg and sevelamer carbonate 2.4 g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2013to Jul 2014
- 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
- Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen
- If currently on 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 laboratory measurement:
- iPTH ≤ 1000 pg/mL at screening (including results obtained within 60 days prior to screening)
- If not taking a phosphate binder, a serum phosphorus measurement >5.5 mg/dL (1.78 mmol/L) at Screening (Visit 1).
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- If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.78 mmol/L) after the two-weeks washout period at Visit 1a (Day 0).
- Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study
- Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study
- Willing and able to maintain screening doses of vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
- If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices
- For patients not on dialysis expecting not to initiate dialysis for the duration of this study
- Signed 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 dysphagia or swallowing disorder
- Predisposition or current bowel obstruction,
- Severe gastrointestinal (GI) motility disorders including severe constipation
- 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
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- Planned renal transplant or parathyroidectomy within 3 months of Visit 1
- Pregnant or breast-feeding
- Evidence of active malignancy except for basal cell carcinoma of the skin
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients
Primary Objective:
Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
Secondary Objective:
Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)
Read the detailed description
10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period
- Conditions
- Renal Failure Chronic
- Being tested
- sevelamer carbonate 800mg, sevelamer carbonate 2.4 g
- 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.
sevelamer carbonate 800mgDrug
Also called Renvela
Pharmaceutical form:tablet
Route of administration: oral
sevelamer carbonate 2.4 gDrug
Also called Renvela
Pharmaceutical form:powder
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| CKD patients not on dialysis 800 mg | Experimental | Sevelamer carbonate 800 mg in tabs 3 times per day with meals Receives: Drug: sevelamer carbonate 800mg |
| CKD patients not on dialysis 2.4 g | Experimental | Sevelamer carbonate 2.4 g powder carbonate per day Receives: Drug: sevelamer carbonate 2.4 g |
| CKD patients on dialysis 800 mg | Experimental | Sevelamer carbonate 800 mg in tabs 3 times per day with meals Receives: Drug: sevelamer carbonate 800mg |
| CKD patients on dialysis 2.4 g | Experimental | Sevelamer carbonate 2.4 g powder carbonate per day Receives: Drug: sevelamer carbonate 2.4 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332811
- Sponsor's protocol ID
- SVCARB10012
- Other IDs
- U1111-1160-6394
- Acronym
- TOSCANA
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2014
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT02332811
- Acronym / sponsor ID
- TOSCANA / SVCARB10012
- Conditions
- Renal Failure Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Jan 2015 (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.
Primary Objective:
Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
Secondary Objective:
Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)
Detailed description
10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD patients not on dialysis 800 mg | Experimental | Drug: sevelamer carbonate 800mgSevelamer carbonate 800 mg in tabs 3 times per day with meals |
| CKD patients not on dialysis 2.4 g | Experimental | Drug: sevelamer carbonate 2.4 gSevelamer carbonate 2.4 g powder carbonate per day |
| CKD patients on dialysis 800 mg | Experimental | Drug: sevelamer carbonate 800mgSevelamer carbonate 800 mg in tabs 3 times per day with meals |
| CKD patients on dialysis 2.4 g | Experimental | Drug: sevelamer carbonate 2.4 gSevelamer carbonate 2.4 g powder carbonate per 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)
- Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen
- If currently on 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 laboratory measurement:
- Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study
Key exclusion criteria (13 listed)
- Active dysphagia or swallowing disorder
- Predisposition or current bowel obstruction,
- Severe gastrointestinal (GI) motility disorders including severe constipation
- Active ethanol or drug abuse, excluding tobacco use
- Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
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 800mgAlso: RenvelaPharmaceutical form:tablet Route of administration: oral | Drug | CKD patients not on dialysis 800 mg, CKD patients on dialysis 800 mg |
| sevelamer carbonate 2.4 gAlso: RenvelaPharmaceutical form:powder Route of administration: oral | Drug | CKD patients not on dialysis 2.4 g, CKD patients on dialysis 2.4 g |
Primary outcome
The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
Time frame: up to 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 Dec 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site 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 800mg and sevelamer carbonate 2.4 g in people with Renal Failure Chronic, run by Genzyme, a Sanofi Company at 1 site in Russia.
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 13 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis (time frame: up to 8 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 23 Dec 2016.