Clinical trial NCT00268957: Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Diseases
Chronic Renal Insufficiency
End-Stage Renal Disease
Keywords: Chronic
Hemodialysis
Kidney
Hyperphosphatemia
Chronic kidney disease
Chronic Renal Insufficiency
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 24 weeks
measure: Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: 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
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center
state: Alabama
city: Gadsden
country: United States
facility: Gadsden Dialysis
state: Alabama
city: Mission Hills
country: United States
facility: Holy Cross Renal Care
state: California
city: Tarzana
country: United States
facility: Nephrology Educational Services and Research
state: California
city: Crystal River
country: United States
facility: Crystal Rivers Dialysis Center
state: Florida
city: Hudson
country: United States
facility: Outcomes Research International, Inc.
state: Florida
city: Atlanta
country: United States
facility: Central Dialysis Center
state: Georgia
city: Decatur
country: United States
facility: Atlanta Nephrology Referral Center
state: Georgia
city: Marietta
country: United States
facility: FMC Marietta
state: Georgia
city: Flossmoor
country: United States
facility: Horizon Healthcare Associates
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation, Nephrology Research
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Brookhaven
country: United States
facility: Southwest Mississippi Nephrology, PLLC
state: Mississippi
city: Columbus
country: United States
facility: Nephrology Associates, P.C.
state: Mississippi
city: Tupelo
country: United States
facility: Nephrology & Hypertension Associates, LTD
state: Mississippi
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Eatontown
country: United States
facility: Hypertension and Nephrology Associates
state: New Jersey
city: Bronx
country: United States
facility: Davita
state: New York
city: Mineola
country: United States
facility: Winthrop University Dialysis Center
state: New York
city: Cincinnati
country: United States
facility: Kidney and Hypertension Center
state: Ohio
city: Cleveland
country: United States
facility: Renal Care Group
state: Ohio
city: Lewistown
country: United States
facility: Lewiston Dialysis Center
state: Pennsylvania
city: Dyersburg
country: United States
facility: Medical Nephrology Associates
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates, P.C.
state: Tennessee
city: Houston
country: United States
facility: Renal Research Inc. at the Kidney Institute
state: Texas
city: Charlottesville
country: United States
facility: Gambro Healthcare - Charlottesville
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research of Tidewater
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University, Division of Nephrology
state: Virginia
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: