Clinical trial NCT00196755: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peritoneal Dialysis
Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum calcium- phosphorus (CaxPO4) product
timeFrame: 12 weeks
measure: Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides
timeFrame: 12 weeks
measure: Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Fredericia
country: Denmark
facility: Fredericia Sygehus
city: Herlev
country: Denmark
facility: Copenhagen University Hospital
city: Århus N
country: Denmark
facility: Aarhus University Hospital
city: Caen
country: France
facility: CHRU Clémenceau
city: Palermo
country: Italy
facility: Ospedale civico e benfratelli
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
city: Amsterdam
country: Netherlands
facility: AMC
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Birmingham
country: United Kingdom
facility: University Hospital ,Queen Elizabeth Hospital
city: Buckinghamshire
country: United Kingdom
facility: High Wycombe Hospital
city: Cardiff
country: United Kingdom
facility: University of Wales College of Medicine
city: Glasgow
country: United Kingdom
facility: Glasgow Western Infirmary
city: London
country: United Kingdom
facility: Royal Hospital The Royal London
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes General Hospital
city: Oxford
country: United Kingdom
facility: The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: