Kidney DiseasesPhase 3NCT00268957
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
A Phase 3 study testing Sevelamer carbonate (Renvela®) and Sevelamer hydrochloride (Renagel®) in people with Kidney Diseases and Chronic Renal Insufficiency, run by Genzyme, a Sanofi Company at 29 sites in United States.
Trial summary
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Chronic Renal Insufficiency, End-Stage Renal Disease
- What is being tested?
- Sevelamer carbonate (Renvela®) and Sevelamer hydrochloride (Renagel®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 29 sitesUnited States
- 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
- On three times per week hemodialysis for three months or longer
- Currently on a phosphate binder(s)
- Considered compliant with phosphate binders and hemodialysis therapy
- Willing to avoid any intentional changes in diet such as fasting or dieting
- Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
- Have the following central laboratory measurements: a.A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
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- Have 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
- Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
- Willing and able to maintain screening doses of lipid medication 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 the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
- Life expectancy of 12 months or greater
- Willing and able to provide informed consent
Who cannot join
- Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
- Active ethanol or drug abuse, excluding tobacco use
- In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
- Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
- Known hypersensitivity to sevelamer or any constituents of the study drug
- Pregnant or breast-feeding
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- Evidence of active malignancy except for basal cell carcinoma of the skin
- Unable to comply with the requirements of the study
- Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Central Dialysis Center
Atlanta, Georgia, 30329
Clinical Research Center
Birmingham, Alabama, 35213
Southwest Mississippi Nephrology, PLLC
Brookhaven, Mississippi, 39601
Gambro Healthcare - Charlottesville
Charlottesville, Virginia, 22902
Kidney and Hypertension Center
Cincinnati, Ohio, 45220
Renal Care Group
Cleveland, Ohio, 44109
Nephrology Associates, P.C.
Columbus, Mississippi, 39705
Crystal Rivers Dialysis Center
Crystal River, Florida, 34429
Atlanta Nephrology Referral Center
Decatur, Georgia, 30030
Henry Ford Hospital
Detroit, Michigan, 48202
Medical Nephrology Associates
Dyersburg, Tennessee, 38024
Hypertension and Nephrology Associates
Eatontown, New Jersey, 07724
Horizon Healthcare Associates
Flossmoor, Illinois, 60422
Gadsden Dialysis
Gadsden, Alabama, 35901
Renal Research Inc. at the Kidney Institute
Houston, Texas, 77054
Outcomes Research International, Inc.
Hudson, Florida, 34667
Indiana University Hospital
Indianapolis, Indiana, 46202
Lewiston Dialysis Center
Lewistown, Pennsylvania, 17044
FMC Marietta
Marietta, Georgia, 30066
Winthrop University Dialysis Center
Mineola, New York, 11501
Holy Cross Renal Care
Mission Hills, California, 91345
Nephrology Associates, P.C.
Nashville, Tennessee, 37205
Ochsner Clinic Foundation, Nephrology Research
New Orleans, Louisiana, 70121
Clinical Research of Tidewater
Norfolk, Virginia, 23507
Virginia Commonwealth University, Division of Nephrology
Richmond, Virginia, 23298
Washington University School of Medicine
St Louis, Missouri, 63110
Nephrology Educational Services and Research
Tarzana, California, 91356
Davita
The Bronx, New York, 10461
Nephrology & Hypertension Associates, LTD
Tupelo, Mississippi, 38801
About this study
Official title: A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.
- Being tested
- Sevelamer carbonate (Renvela®), Sevelamer hydrochloride (Renagel®)
- Keywords
- Chronic, Hemodialysis, Kidney, Hyperphosphatemia, Chronic kidney disease, Chronic Renal Insufficiency
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Kidney Failure, Chronic, Bronchiolitis Obliterans Syndrome, 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 powder dosed once per day with largest meal
Sevelamer hydrochloride (Renagel®)Drug
Sevelamer hydrochloride tablets dosed three times a day with meals
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | sevelamer carbonate powder Receives: Drug: Sevelamer carbonate (Renvela®) |
| 2 | Active comparator | Sevelamer hydrochloride Receives: Drug: Sevelamer hydrochloride (Renagel®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus
Measured: Up to 24 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals
Measured: Up to 24 weeks
Secondary outcomes (1)
Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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 Kidney DiseasesStudies 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
- 217 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
- NCT00268957
- Sponsor's protocol ID
- GD3-199-301
- Status last verified
- Mar 2014
- First submitted
- 22 Dec 2005
- 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 Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT00268957
- Acronym / sponsor ID
- GD3-199-301
- Keywords
- Chronic, Hemodialysis, Kidney, Hyperphosphatemia, Chronic kidney disease, Chronic Renal Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 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
- 23 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.
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sevelamer carbonate (Renvela®)sevelamer carbonate powder |
| 2 | Active comparator | Drug: Sevelamer hydrochloride (Renagel®)Sevelamer hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- On three times per week hemodialysis for three months or longer
- Currently on a phosphate binder(s)
- Considered compliant with phosphate binders and hemodialysis therapy
- Willing to avoid any intentional changes in diet such as fasting or dieting
- Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
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
- In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
- Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
- Known hypersensitivity to sevelamer or any constituents of the study drug
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 powder dosed once per day with largest meal | Drug | 1 |
| Sevelamer hydrochloride (Renagel®)Sevelamer hydrochloride tablets dosed three times a day with meals | Drug | 2 |
Primary outcome
Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus
Time frame: Up to 24 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals
Time frame: Up to 24 weeks
1 secondary outcome
Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile
Time frame: Up to 24 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
29 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®) and Sevelamer hydrochloride (Renagel®) in people with Kidney Diseases and Chronic Renal Insufficiency, run by Genzyme, a Sanofi Company at 29 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 14 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 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 29 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 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 efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus (time frame: Up to 24 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 19 Mar 2014.