- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00267514
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
March 17, 2015 updated by: Genzyme, a Sanofi Company
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bristol, United Kingdom, BS10 5NB
- Southmead Hospital
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Cambridge, United Kingdom, CB2 2QQ
- Addenbrooks NHS Trust
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London, United Kingdom, SE1 9RT
- Guy's Hospital
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London, United Kingdom, E1 1BB
- The Royal London Hospital
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Manchester, United Kingdom, M6 8HD
- Hope Hospital
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Manchester, United Kingdom, M13 9WL
- Manchester Royal Infirmary
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Norwich, United Kingdom, NR4 7UY
- Norfolk and Norwich University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks
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sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
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Other: 2
sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks
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sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Up to 13 weeks
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Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals
Time Frame: Up to 13 weeks
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Up to 13 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Up to 13 weeks
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serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)
Time Frame: Up to 13 weeks
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Up to 13 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
December 20, 2005
First Submitted That Met QC Criteria
December 20, 2005
First Posted (Estimate)
December 21, 2005
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVCARB00205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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