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

Primary Purpose

Peritoneal Dialysis, Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sevelamer Hydrochloride (Renagel®)
Calcium acetate (PhosLo® )
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ Gasthuisberg
  • Fredericia Sygehus
  • Copenhagen University Hospital
  • Aarhus University Hospital
  • CHRU Clémenceau
  • Ospedale civico e benfratelli
  • Ospedale San Bortolo
  • AMC
  • Fundacion Jimenez Diaz
  • Hospital Universitario La Paz
  • University Hospital ,Queen Elizabeth Hospital
  • High Wycombe Hospital
  • University of Wales College of Medicine
  • Glasgow Western Infirmary
  • Royal Hospital The Royal London
  • Milton Keynes General Hospital
  • The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sevelamer Hydrochloride (Renagel®)

Calcium acetate (PhosLo® )

Arm Description

Outcomes

Primary Outcome Measures

Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.

Secondary Outcome Measures

Serum calcium- phosphorus (CaxPO4) product
Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides
Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein

Full Information

First Posted
September 15, 2005
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00196755
Brief Title
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevelamer Hydrochloride (Renagel®)
Arm Type
Experimental
Arm Title
Calcium acetate (PhosLo® )
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sevelamer Hydrochloride (Renagel®)
Intervention Description
Sevelamer hydrochloride three times per day with each meal
Intervention Type
Drug
Intervention Name(s)
Calcium acetate (PhosLo® )
Intervention Description
Calcium acetate three times per day with each meal
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Serum calcium- phosphorus (CaxPO4) product
Time Frame
12 weeks
Title
Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides
Time Frame
12 weeks
Title
Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Fredericia Sygehus
City
Fredericia
ZIP/Postal Code
DN-7000
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Herlev
ZIP/Postal Code
DN-2730
Country
Denmark
Facility Name
Aarhus University Hospital
City
Århus N
ZIP/Postal Code
DN-8200
Country
Denmark
Facility Name
CHRU Clémenceau
City
Caen
ZIP/Postal Code
FR-14033
Country
France
Facility Name
Ospedale civico e benfratelli
City
Palermo
ZIP/Postal Code
IT-90127
Country
Italy
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
IT-36100
Country
Italy
Facility Name
AMC
City
Amsterdam
ZIP/Postal Code
NL-1105 AZ
Country
Netherlands
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
ES-28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
ES-28046
Country
Spain
Facility Name
University Hospital ,Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
High Wycombe Hospital
City
Buckinghamshire
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Facility Name
University of Wales College of Medicine
City
Cardiff
ZIP/Postal Code
CF 14 4XN
Country
United Kingdom
Facility Name
Glasgow Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Hospital The Royal London
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Milton Keynes General Hospital
City
Milton Keynes
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Facility Name
The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

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

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