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REN00304: Study of Safety and Efficacy of Renagel® Compared with Calcium Acetate in Patients with Peritoneal Dialysis
This study has been completed.
Sponsored By:
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Genzyme
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Information Provided By:
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Genzyme
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ClinicalTrials.gov Identifier:
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NCT00196755
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Purpose
The purpose of this study is to determine if Renagel® is more effective as a treatment for patients with peritoneal dialysis compared to calcium acetate.
Condition
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Intervention
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Phase
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Peritoneal Dialysis
Chronic Kidney Disease
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Drug: Sevelamer Hydrochloride (Renagel®)
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Phase III
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Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared with Calcium Acetate in Peritoneal Dialysis Patients
Further Study Details:
Primary Outcomes: Compare the effects of sevelamer dosed TID and calcium acetate dosed TID on serum phosphorus.
Secondary Outcomes: Serum calcium- phosphorus (CaxPO4) product; Serum lipids; Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
Expected Total Enrollment: 138
Study start: December 2004; February 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
 | Willing and able to sign an informed consent form.
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 | Men or women aged 18 years of age or older.
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 | A diagnosis of CKD and receiving peritoneal dialysis (CAPD, APD or CCPD) for 8 weeks or longer.
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 | In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
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 | Will have a serum phosphorus level >1.76 mmol/L(5.50 mg/dL) after 2 weeks washout from their usual phosphate binder.
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 | Will have serum calcium measurement adjusted for albumin within the range (2.10-2.60 mmol/L (8.40-10.40 mg/dL) following 2 weeks washout from their usual phosphate binder.
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 | Willing to maintain the prescribed sevelamer or calcium acetate for the duration of the study.
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 | Considered compliant with phosphate binders and dialysis.
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 | On a stable doses of medication to treat hyperparathyroidism (Vitamin D or its analogues or calcimimetic agents) for the month prior to screening.
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 | Willing to discontinue use of antacids containing calcium, aluminium or magnesium at screening visit for the duration of the study (unless taken as an evening calcium supplement as prescribed by the investigator per protocol).
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 | Willing to avoid intentional changes in diet such as fasting or dieting.
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 | 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 IUDs.
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 | Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel. |
Exclusion Criteria:
 | Patients with a history of peritonitis in the last 30 days or > 2 episodes in the last 12 months
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 | Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder.
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 | Patients who in the opinion of the investigator have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant, unstable medical condition.
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 | Patients with any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not exclusion.
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 | Current use of an antiarrhythmic medication such as quinidine, procainamide, tocainide, or amiodarone for the control of arrhythmias.
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 | Current use of a seizure medication such as phenytoin, phenobarbital, valproate, or carbamazepine for the control of a seizure disorder.
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 | Active ethanol or drug abuse, excluding tobacco use.
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 | If female, are pregnant, planning on becoming pregnant in the next 6 months or breast-feeding.
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 | Patients with a known hypersensitivity to sevelamer or any constituents of either study drug.
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 | Patients who have participated in a study of an investigational drug/device during the 30 days preceding the start of the screening period.
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 | Patients who have any other condition, which in the opinion of the investigator will prohibit the patient’s participation in the study.
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 | Patient is unable to comply with the requirements of the protocol. |
Location and Contact Information
Belgium
UZ Gasthuisberg, Leuven, B-3000, Belgium
Denmark
Aarhus University Hospital, Århus N, DN-8200, Denmark
Copenhagen University Hospital, Herlev, DN-2730, Denmark
Fredericia Sygehus, Fredericia, DN-7000, Denmark
France
CHRU Clémenceau, Caen, FR-14033, France
Italy
Ospedale San Bortolo, Vicenza, IT-36100, Italy
Ospedale civico e benfratelli, Palermo, IT-90127, Italy
Netherlands
AMC, Amsterdam, NL-1105 AZ, Netherlands
Spain
Hospital Universitario La Paz, Madrid, ES-28046, Spain
Fundacion Jimenez Diaz, Madrid, ES-28040, Spain
United Kingdom
University of Wales College of Medicine, Cardiff, CF 14 4XN, United Kingdom
Royal Hospital The Royal London, London, E1 1BB, United Kingdom
The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust, Oxford, OX3 7LJ, United Kingdom;
University Hospital, Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom
Glasgow Western Infirmary, Glasgow, G11 6NT, United Kingdom
High Wycombe Hospital, Buckinghamshire, HP11 2TT, United Kingdom
Milton Keynes General Hospital, Milton Keynes, MK6 5LD, United Kingdom
More Information
US FDA Approved Full Prescribing Information for Renagel®
Study ID Numbers: REN00304
ClinicalTrials.gov Identifier: NCT00196755
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Belgium: Directorate general for the protection of Public health: Medicines
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Contact Information
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142
T:617 252 7500
F:617 252 7600
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