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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.
Information provided by:
Sanofi Identifier:
First received: September 15, 2005
Last updated: March 17, 2015
Last verified: March 2015
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.

Condition Intervention Phase
Peritoneal Dialysis
Chronic Kidney Disease
Drug: Sevelamer Hydrochloride (Renagel®)
Drug: Calcium acetate (PhosLo® )
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Sanofi:

Primary Outcome Measures:
  • Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Serum calcium- phosphorus (CaxPO4) product [ Time Frame: 12 weeks ]
  • Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides [ Time Frame: 12 weeks ]
  • Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein [ Time Frame: 12 weeks ]

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
Experimental: Sevelamer Hydrochloride (Renagel®) Drug: Sevelamer Hydrochloride (Renagel®)
Sevelamer hydrochloride three times per day with each meal
Active Comparator: Calcium acetate (PhosLo® ) Drug: Calcium acetate (PhosLo® )
Calcium acetate three times per day with each meal


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Willing and able to sign an informed consent form.
  • Men or women aged 18 years of age or older.
  • A diagnosis of Chronic Kidney Disease (CKD) and receiving peritoneal dialysis (Continuous cyclical peritoneal dialysis (CAPD), Automated peritoneal dialysis (APD) or Continuous cyclical peritoneal dialysis (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 Intrauterine devices (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, Human Immunodeficiency Virus (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
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Please refer to this study by its identifier: NCT00196755

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

Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00196755     History of Changes
Other Study ID Numbers: REN00304
Study First Received: September 15, 2005
Last Updated: March 17, 2015

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Calcium, Dietary
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017