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

Genzyme

Status and phase

Completed

Phase 3

Conditions

Chronic Kidney Disease

Hyperphosphatemia

Treatments

Drug: Sevelamer carbonate (Renvela®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00681941

SVCARB00105

ACTRN012606000380594

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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