Chronic Kidney DiseasePhase 3NCT00267514
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
A Phase 3 study testing sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) and sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) in people with Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 7 sites in United Kingdom.
Trial summary
The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) and sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Jan 2006to May 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
- Receiving three times per week haemodialysis for three months or longer.
- Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosphate binders concomitantly) not exceeding a total daily binder dose of 14.4 g, for at least 60 days prior to screening.
- Have the following documented local laboratory measurements:
- Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 7.0 mg/dL (≥ 0.96 and ≤ 2.26 mmol/L) within 60 days of screening
- An most recent iPTH measurement ≤ 900 pg/mL (< 99 pmol/L) within 90 days of screening
- A most recent serum calcium (adjusted for albumin) measurement within normal range defined by the local laboratory within 60 days of screening
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- Have the following central laboratory measurements:
- A serum phosphorus measurement ≥ 5.5 mg/dL (≥ 1.76 mmol/L) at Visit 2 (after Washout)
- A serum iPTH measurement ≤ 800 pg/mL at Visit 5 (prior to randomization)
- A serum phosphorus measurement ≥ 3.0 and ≤ 6.5 mg/dL (≥ 0.96 and ≤ 2.08 mmol/L) at Visit 5
- If on vitamin D replacement or calcimimetics therapy, be at a stable dose for at least one month prior to screening and willing to maintain the same dose throughout the duration of the study, except for safety reasons.
- Willing to maintain screening doses of lipid medication for the duration of the study, except for safety reasons.
- Willing to avoid any intentional changes in diet such as fasting or dieting.
- 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 intrauterine devices (IUDs).
- Willing to stop all calcium supplements not prescribed by the investigator including multivitamins containing calcium.
- Willing to refrain from using aluminium, calcium, lanthanum, or magnesium containing antacids throughout duration of the study unless prescribed by the investigator as a calcium supplement per protocol.
- Have a level of understanding and willingness to cooperate with all visits and procedures, including telephone contacts, as described in the consent by the study site personnel.
Who cannot join
- Have poorly controlled diabetes mellitus or hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition (defined by investigator).
- Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
- Have participated in a study of an investigational drug during the 30 days preceding the start of the screening period.
- Has active ethanol or drug dependence or abuse, excluding tobacco use.
- Have any other condition, which, in the investigator's opinion, will prohibit the patient's participation in the study.
- If female, be pregnant or breast-feeding.
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- Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
- Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- Have a known hypersensitivity to sevelamer or any of its constituents.
- Have a poor record of compliance with medication.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Southmead Hospital
Bristol, BS10 5NB
Addenbrooks NHS Trust
Cambridge, CB2 2QQ
The Royal London Hospital
London, E1 1BB
Guy's Hospital
London, SE1 9RT
Manchester Royal Infirmary
Manchester, M13 9WL
Hope Hospital
Manchester, M6 8HD
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
About this study
Official title: A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients
The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.
- Conditions
- Chronic Kidney Disease
- Being tested
- sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®), sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
- 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.
sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)Drug
sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)Drug
sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks Receives: Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) |
| 2 | Other | sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks Receives: Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels
Measured: Up to 13 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals
Measured: Up to 13 weeks
Secondary outcomes (2)
Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product
Measured: Up to 13 weeks
serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionMay 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT00267514
- Sponsor's protocol ID
- SVCARB00205
- Status last verified
- Mar 2015
- First submitted
- 20 Dec 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT00267514
- Acronym / sponsor ID
- SVCARB00205
- Conditions
- Chronic Kidney Disease
- Keywords
- Hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 21 Dec 2005 (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 purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks |
| 2 | Other | Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Receiving three times per week haemodialysis for three months or longer.
- Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosphate binders concomitantly) not exceeding a total daily binder dose of 14.4 g, for at least 60 days prior to screening.
- Have the following documented local laboratory measurements:
- Have the following central laboratory measurements:
- If on vitamin D replacement or calcimimetics therapy, be at a stable dose for at least one month prior to screening and willing to maintain the same dose throughout the duration of the study, except for safety reasons.
Key exclusion criteria (10 listed)
- Have poorly controlled diabetes mellitus or hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition (defined by investigator).
- Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
- Have participated in a study of an investigational drug during the 30 days preceding the start of the screening period.
- Has active ethanol or drug dependence or abuse, excluding tobacco use.
- Have any other condition, which, in the investigator's opinion, will prohibit the patient's participation in the study.
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 hydrochloride (Renagel ®)sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks | Drug | 1 |
| sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks | Drug | 2 |
Primary outcome
Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels
Time frame: Up to 13 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals
Time frame: Up to 13 weeks
2 secondary outcomes
Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product
Time frame: Up to 13 weeks
serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)
Time frame: Up to 13 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 18 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
7 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 (Renvela®) sevelamer hydrochloride (Renagel ®) and sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) in people with Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 7 sites in United Kingdom.
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 17 inclusion and 10 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 18 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 7 sites in United Kingdom. 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?
Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels (time frame: Up to 13 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 18 Mar 2015.