Chronic Kidney DiseasePhase 2NCT00440648
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
A Phase 2 study testing sevelamer carbonate, sevelamer hydrochloride and sevelamer hydrochloride, sevelamer carbonate in people with Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 15 sites in United States.
Trial summary
This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. 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, sevelamer hydrochloride and sevelamer hydrochloride, sevelamer carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2005to Jul 2006
- Phase
- Phase 2
- 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
- patient had received hemodialysis three times per week for 3 months or longer;
- patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.
Who cannot join
- if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
- active ethanol or drug abuse (excluding tobacco);
- need for antidysrhythmic or antiseizure medications used to control these conditions;
- poorly controlled diabetes mellitus or hypertension;
- active vasculitis;
- active malignancy other than basal-cell carcinoma;
- HIV infection; or
- any clinically significant unstable medical condition as judge by the Investigator.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Berwyn, Illinois, 60402
Study site
Columbus, Missouri, 39705
Study site
Crestwood, Illinois, 60445
Study site
Easton, Pennsylvania, 19045
Study site
Greenwood Village, Colorado, 80111
Study site
Indianapolis, Indiana, 46202
Study site
Mobile, Alabama, 36608
Study site
Nashville, Tennessee, 37205
Study site
Norfolk, Virginia, 23507
Study site
Riverside, California, 92501
Study site
St Louis, Missouri, 63103
Study site
St Louis, Missouri, 63110
Study site
Valparaiso, Indiana, 46383
Study site
Winston-Salem, North Carolina, 27157
Study site
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks
Read the detailed description
The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.
- Conditions
- Chronic Kidney Disease
- Being tested
- sevelamer carbonate, sevelamer hydrochloride, sevelamer hydrochloride, sevelamer carbonate
- 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, sevelamer hydrochlorideDrug
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
sevelamer hydrochloride, sevelamer carbonateDrug
Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | sevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16) Receives: Drug: sevelamer carbonate, sevelamer hydrochloride |
| 2 | Other | sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16) Receives: Drug: sevelamer hydrochloride, sevelamer carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-evaluated on the basis of adverse events (reported and/or observed)
Measured: 16 weeks
changes in laboratory parameters, vital signs
Measured: 16 weeks
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
Measured: 16 weeks
Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period
Measured: 16 weeks
Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionJul 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT00440648
- Sponsor's protocol ID
- GD3-163-201
- Status last verified
- Mar 2014
- First submitted
- 24 Feb 2007
- Last updated
- 19 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT00440648
- Acronym / sponsor ID
- GD3-163-201
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 27 Feb 2007 (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.
This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks
Detailed description
The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: sevelamer carbonate, sevelamer hydrochloridesevelamer carbonate w(1-8) sevelamer hydrochloride w(9-16) |
| 2 | Other | Drug: sevelamer hydrochloride, sevelamer carbonatesevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient had received hemodialysis three times per week for 3 months or longer;
- patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL, the most recent iPTH ≤ 600 pg/mL and the most recent serum calcium within the normal range.
Key exclusion criteria (8 listed)
- if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
- active ethanol or drug abuse (excluding tobacco);
- need for antidysrhythmic or antiseizure medications used to control these conditions;
- poorly controlled diabetes mellitus or hypertension;
- active vasculitis;
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, sevelamer hydrochlorideStarting dose individualized for each patient and fixed daily dose throughout both treatment periods | Drug | 1 |
| sevelamer hydrochloride, sevelamer carbonateStarting dose individualized for each patient and fixed daily dose throughout both treatment periods | Drug | 2 |
Primary outcome
Safety-evaluated on the basis of adverse events (reported and/or observed)
Time frame: 16 weeks
changes in laboratory parameters, vital signs
Time frame: 16 weeks
note: clinically significant changes in physical examination were recorded and evaluated as adverse events
Time frame: 16 weeks
Efficacy-treatment regimens are compared on the basis of serum phosphorus at the end of each treatment period using the time-weighted mean of the phosphorus value from the last three visits in each treatment period
Time frame: 16 weeks
Treatment regimens were also compared with respect to total, LDL, and HDL cholesterol, and triglycerides, using the mean of values for each parameter from the two post-baseline assessments in each treatment period.
Time frame: 16 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 19 Mar 2014.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sevelamer carbonate, sevelamer hydrochloride and sevelamer hydrochloride, sevelamer carbonate in people with Chronic Kidney Disease, run by Genzyme, a Sanofi Company at 15 sites in United States.
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 2 inclusion and 8 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety-evaluated on the basis of adverse events (reported and/or observed) (time frame: 16 weeks). The study lists 5 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 19 Mar 2014.