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

Condition(s) targeted: Peritoneal Dialysis; Chronic Kidney Disease

Intervention: Sevelamer Hydrochloride (Renagel®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Genzyme

Official(s) and/or principal investigator(s):
Ajay Duggal, M.D., Study Director, Affiliation: Genzyme

The purpose of this study is to determine if Renagel® is more effective as a treatment for patients with peritoneal dialysis compared to calcium acetate.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Compare the effects of sevelamer dosed TID and calcium acetate dosed TID on serum phosphorus.

Secondary outcome:

Serum calcium- phosphorus (CaxPO4) product

Serum lipids

Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 CKD and receiving peritoneal dialysis (CAPD, APD or 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 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, 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.

UZ Gasthuisberg, Leuven B-3000, Belgium

Aarhus University Hospital, Århus N DN-8200, Denmark

Copenhagen University Hospital, Herlev DN-2730, Denmark

Fredericia Sygehus, Fredericia DN-7000, Denmark

CHRU Clémenceau, Caen FR-14033, France

Ospedale San Bortolo, Vicenza IT-36100, Italy

Ospedale civico e benfratelli, Palermo IT-90127, Italy

AMC, Amsterdam NL-1105 AZ, Netherlands

Hospital Universitario La Paz, Madrid ES-28046, Spain

Fundacion Jimenez Diaz, Madrid ES-28040, Spain

University of Wales College of Medicine, Cardiff CF 14 4XN, United Kingdom

Royal Hospital The Royal London, London E1 1BB, United Kingdom

The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust, Oxford OX3 7LJ, United Kingdom

University Hospital ,Queen Elizabeth Hospital, Birmingham B15 2TH, United Kingdom

Glasgow Western Infirmary, Glasgow G11 6NT, United Kingdom

High Wycombe Hospital, Buckinghamshire HP11 2TT, United Kingdom

Milton Keynes General Hospital, Milton Keynes MK6 5LD, United Kingdom

US FDA Approved Full Prescribing Information for Renagel®

Starting date: December 2004
Ending date: February 2006
Last updated: July 16, 2007