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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00196755
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Peritoneal Dialysis Chronic Kidney Disease Drug: Sevelamer Hydrochloride (Renagel®) Drug: Calcium acetate (PhosLo® ) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Serum calcium- phosphorus (CaxPO4) product [ Time Frame: 12 weeks ]
  2. Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides [ Time Frame: 12 weeks ]
  3. Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196755


Locations
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Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00196755    
Other Study ID Numbers: REN00304
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium, Dietary
Calcium
Sevelamer
 Calcium acetate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action