An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

NCT ID: NCT00681941

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-03-31

Brief Summary

Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

Conditions

Chronic Kidney Disease; Hyperphosphatemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Sevelamer Carbonate Tablets Dosed Three Times A Day

Group Type: EXPERIMENTAL

Sevelamer carbonate (Renvela®)

Intervention Type: DRUG

Sevelamer Carbonate Tablets Dosed Three Times A Day

Interventions

Sevelamer carbonate (Renvela®)

Sevelamer Carbonate Tablets Dosed Three Times A Day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.
• Men or woman 18 years of age or older
• If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period
• Willing to avoid any intentional changes in diet such as fasting or dieting
• Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
• At Screening (Visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin D ≥ 10 ng/mL 2. iPTH ≤ 800 pg/mL
• Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study
• Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
• Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
• 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
• Expecting not to initiate dialysis for the duration of this study
• Considered compliant with phosphate binders (if applicable)
• Willing and able to provide informed consent
• Has not participated in any other investigational drug studies within 30 days prior to enrollment,
• Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel

Exclusion Criteria

• Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders
• Active ethanol or drug abuse, excluding tobacco use
• Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
• In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
• Pregnant or breast-feeding
• Evidence of active malignancy except for basal cell carcinoma of the skin
• Unable to comply with the requirements of the study
• Known hypersensitivity to sevelamer or any constituents of the study drug
• Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Nephrology Department, Princess Alexandra Hospital

Wooloongabba, Queensland, Australia

Renal Unit, The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Renal Research Unit, Launceston General Hospital

Launceston, Tasmania, Australia

The Royal Melbourne Hospital, Department of Nephrology

Parkville, Victoria, Australia

Melbourne Renal Research Group, Epworth Medical Centre

Richmond, Victoria, Australia

Nyremedicinsk Afdeling, Medicinerhuset

Aalborg, , Denmark

Medicinsk Afdeling

Copenhagen, , Denmark

Nefrologisk Afdeling, Hilleroed Sygehus

Hilleroed, , Denmark

Medicinsk Afdeling, nefrologisk, Roskilde Sygehus

Roskilde, , Denmark

George Pompidou, European Hospital

Paris, , France

Universitätsklinikum Aachen, Medizinsche Klinik II

Aachen, , Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Heimdialysezentrum

Heidelberg, , Germany

KfH Nierenzentrum

Nuremberg, , Germany

Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin

Solingen, , Germany

Nephrologisches Zentrum

Villingen-Schwenningen, , Germany

Birmingham Hospital, Queen Elizabeth Medical Centre

Birmingham, England, United Kingdom

Southmead Hospital

Bristol, England, United Kingdom

Addenbrooke's Dialysis Centre

Cambridge, England, United Kingdom

Leicester General Hospital

Leicester, England, United Kingdom

Renal Department, The Royal London Hospital

London, England, United Kingdom

Renal & Urology SDU Offices

London, England, United Kingdom

Renal Dialysis Unit, Manchester Royal Infirmary

Manchester, England, United Kingdom

Department of Renal Medicine, Hope Hospital

Manchester, England, United Kingdom

Renal Unit, Queen Alexandra Hospital

Portsmouth, England, United Kingdom

Countries

Australia; Denmark; France; Germany; United Kingdom

Other Identifiers

ACTRN012606000380594

Identifier Type: -

Identifier Source: secondary_id

SVCARB00105

Identifier Type: -

Identifier Source: org_study_id