Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis - Full Text View

Sponsor:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00268957

Purpose

Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.

Condition	Intervention	Phase
Kidney Diseases Chronic Renal Insufficiency End-Stage Renal Disease	Drug: Sevelamer carbonate (Renvela®) Drug: Sevelamer hydrochloride (Renagel®)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Sevelamer Sevelamer hydrochloride Sevelamer carbonate

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	217
Study Start Date:	January 2006
Study Completion Date:	May 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 sevelamer carbonate powder	Drug: Sevelamer carbonate (Renvela®) sevelamer carbonate powder dosed once per day with largest meal
Active Comparator: 2 Sevelamer hydrochloride	Drug: Sevelamer hydrochloride (Renagel®) Sevelamer hydrochloride tablets dosed three times a day with meals

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

On three times per week hemodialysis for three months or longer
Currently on a phosphate binder(s)
Considered compliant with phosphate binders and hemodialysis therapy
Willing to avoid any intentional changes in diet such as fasting or dieting
Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
Have the following central laboratory measurements: a.A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
Have 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
Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
Willing and able to maintain screening doses of lipid medication 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 the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
Life expectancy of 12 months or greater
Willing and able to provide informed consent

Exclusion Criteria:

Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
Active ethanol or drug abuse, excluding tobacco use
In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
Known hypersensitivity to sevelamer or any constituents of the study drug
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
Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268957

Show 29 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00268957 History of Changes
Other Study ID Numbers:	GD3-199-301
Study First Received:	December 22, 2005
Last Updated:	July 29, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Chronic
Hemodialysis
Kidney

Hyperphosphatemia
Chronic kidney disease
Chronic Renal Insufficiency

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012