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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00681941
First received: May 19, 2008
Last updated: August 3, 2009
Last verified: December 2007

May 19, 2008
August 3, 2009
January 2006
January 2007   (final data collection date for primary outcome measure)
  • Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals. [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681941 on ClinicalTrials.gov Archive Site
  • Serum calcium-phosphorus product [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
  • Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol] [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
  • Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET [ Time Frame: Up to day 70 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Hyperphosphatemia
Drug: Sevelamer carbonate (Renvela®)
Sevelamer Carbonate Tablets Dosed Three Times A Day
Experimental: 1
Sevelamer Carbonate Tablets Dosed Three Times A Day
Intervention: Drug: Sevelamer carbonate (Renvela®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
March 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   France,   Germany,   United Kingdom
 
NCT00681941
SVCARB00105, ACTRN012606000380594
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP