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Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
This study has been completed.
First Received: September 15, 2005   Last Updated: July 31, 2009   History of Changes
Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00196755
  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 Intervention Phase
Peritoneal Dialysis
Chronic Kidney Disease
Drug: Sevelamer Hydrochloride (Renagel®)
Drug: Calcium acetate (PhosLo® )
Phase III

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

Resource links provided by NLM:


Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Compare the effects of sevelamer dosed TID and calcium acetate dosed TID on serum phosphorus. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum calcium- phosphorus (CaxPO4) product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: December 2004
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
sevelamer hydrochloride
Drug: Sevelamer Hydrochloride (Renagel®)
Sevelamer hydrochloride three times per day with each meal
2: Active Comparator
Calcium acetate
Drug: Calcium acetate (PhosLo® )
Calcium acetate three times per day with each meal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to sign an informed consent form.
  • Men or women aged 18 years of age or older.
  • A diagnosis of CKD and receiving peritoneal dialysis (CAPD, APD or CCPD) for 8 weeks or longer.
  • In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
  • Will have a serum phosphorus level >1.76 mmol/L(5.50 mg/dL) after 2 weeks washout from their usual phosphate binder.
  • 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.
  • Willing to maintain the prescribed sevelamer or calcium acetate for the duration of the study.
  • Considered compliant with phosphate binders and dialysis.
  • On a stable doses of medication to treat hyperparathyroidism (Vitamin D or its analogues or calcimimetic agents) for the month prior to screening.
  • 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).
  • Willing to avoid 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 IUDs.
  • 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
  • Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder.
  • 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.
  • Patients with any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not exclusion.
  • Current use of an antiarrhythmic medication such as quinidine, procainamide, tocainide, or amiodarone for the control of arrhythmias.
  • Current use of a seizure medication such as phenytoin, phenobarbital, valproate, or carbamazepine for the control of a seizure disorder.
  • Active ethanol or drug abuse, excluding tobacco use.
  • If female, are pregnant, planning on becoming pregnant in the next 6 months or breast-feeding.
  • Patients with a known hypersensitivity to sevelamer or any constituents of either study drug.
  • Patients who have participated in a study of an investigational drug/device during the 30 days preceding the start of the screening period.
  • Patients who have any other condition, which in the opinion of the investigator will prohibit the patient's participation in the study.
  • Patient is unable to comply with the requirements of the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196755

Locations
Belgium
UZ Gasthuisberg
Leuven, Belgium, B-3000
Denmark
Aarhus University Hospital
Århus N, Denmark, DN-8200
Copenhagen University Hospital
Herlev, Denmark, DN-2730
Fredericia Sygehus
Fredericia, Denmark, DN-7000
France
CHRU Clémenceau
Caen, France, FR-14033
Italy
Ospedale San Bortolo
Vicenza, Italy, IT-36100
Ospedale civico e benfratelli
Palermo, Italy, IT-90127
Netherlands
AMC
Amsterdam, Netherlands, NL-1105 AZ
Spain
Hospital Universitario La Paz
Madrid, Spain, ES-28046
Fundacion Jimenez Diaz
Madrid, Spain, ES-28040
United Kingdom
University of Wales College of Medicine
Cardiff, United Kingdom, CF 14 4XN
Royal Hospital The Royal London
London, United Kingdom, E1 1BB
The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LJ
Milton Keynes General Hospital
Milton Keynes, United Kingdom, MK6 5LD
Glasgow Western Infirmary
Glasgow, United Kingdom, G11 6NT
High Wycombe Hospital
Buckinghamshire, United Kingdom, HP11 2TT
University Hospital ,Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Additional Information:
No publications provided

Responsible Party: Genzyme Corporation ( Medical Monitor )
Study ID Numbers: REN00304
Study First Received: September 15, 2005
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00196755     History of Changes
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

Study placed in the following topic categories:
Calcium, Dietary
Sevelamer
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Chelating Agents
Kidney Diseases
Calcium acetate
Kidney Failure

Additional relevant MeSH terms:
Sevelamer
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Chelating Agents
Kidney Diseases
Calcium acetate
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on September 03, 2009