Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00196755
First received: September 15, 2005
Last updated: October 5, 2010
Last verified: October 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 Genzyme, a Sanofi Company:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum calcium- phosphorus (CaxPO4) product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides [ 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
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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196755

Locations
Belgium
UZ Gasthuisberg
Leuven, Belgium, B-3000
Denmark
Fredericia Sygehus
Fredericia, Denmark, DN-7000
Copenhagen University Hospital
Herlev, Denmark, DN-2730
Aarhus University Hospital
Århus N, Denmark, DN-8200
France
CHRU Clémenceau
Caen, France, FR-14033
Italy
Ospedale civico e benfratelli
Palermo, Italy, IT-90127
Ospedale San Bortolo
Vicenza, Italy, IT-36100
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 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
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00196755     History of Changes
Other Study ID Numbers: REN00304
Study First Received: September 15, 2005
Last Updated: October 5, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Calcium, Dietary
Sevelamer
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014