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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196755
• Other study ID #: REN00304
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: March 17, 2015
• Start date: December 2004
• Est. completion date: April 2006

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Peritoneal Dialysis
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sevelamer Hydrochloride (Renagel®)
Sevelamer hydrochloride three times per day with each meal
• Calcium acetate (PhosLo® )
Calcium acetate three times per day with each meal

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Denmark	Aarhus University Hospital	Århus N
Denmark	Fredericia Sygehus	Fredericia
Denmark	Copenhagen University Hospital	Herlev
France	CHRU Clémenceau	Caen
Italy	Ospedale civico e benfratelli	Palermo
Italy	Ospedale San Bortolo	Vicenza
Netherlands	AMC	Amsterdam
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
United Kingdom	University Hospital ,Queen Elizabeth Hospital	Birmingham
United Kingdom	High Wycombe Hospital	Buckinghamshire
United Kingdom	University of Wales College of Medicine	Cardiff
United Kingdom	Glasgow Western Infirmary	Glasgow
United Kingdom	Royal Hospital The Royal London	London
United Kingdom	Milton Keynes General Hospital	Milton Keynes
United Kingdom	The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.		12 weeks	No
Secondary	Serum calcium- phosphorus (CaxPO4) product		12 weeks	No
Secondary	Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides		12 weeks	No
Secondary	Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein		12 weeks	No