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

September 15, 2005
October 5, 2010
December 2004
March 2006   (final data collection date for primary outcome measure)
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 ]
Compare the effects of sevelamer dosed TID and calcium acetate dosed TID on serum phosphorus.
Complete list of historical versions of study NCT00196755 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Serum calcium- phosphorus (CaxPO4) product
  • Serum lipids
  • Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
Not Provided
Not Provided
 
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peritoneal Dialysis
  • Chronic Kidney Disease
  • Drug: Sevelamer Hydrochloride (Renagel®)
    Sevelamer hydrochloride three times per day with each meal
  • Drug: Calcium acetate (PhosLo® )
    Calcium acetate three times per day with each meal
  • Experimental: Sevelamer Hydrochloride (Renagel®)
    Intervention: Drug: Sevelamer Hydrochloride (Renagel®)
  • Active Comparator: Calcium acetate (PhosLo® )
    Intervention: Drug: Calcium acetate (PhosLo® )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
April 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   France,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00196755
REN00304
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP