Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268957
• Other study ID #: GD3-199-301
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: March 17, 2014
• Start date: January 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sevelamer carbonate (Renvela®)
sevelamer carbonate powder dosed once per day with largest meal
• Sevelamer hydrochloride (Renagel®)
Sevelamer hydrochloride tablets dosed three times a day with meals

Locations

Country	Name	City	State
United States	Central Dialysis Center	Atlanta	Georgia
United States	Clinical Research Center	Birmingham	Alabama
United States	Davita	Bronx	New York
United States	Southwest Mississippi Nephrology, PLLC	Brookhaven	Mississippi
United States	Gambro Healthcare - Charlottesville	Charlottesville	Virginia
United States	Kidney and Hypertension Center	Cincinnati	Ohio
United States	Renal Care Group	Cleveland	Ohio
United States	Nephrology Associates, P.C.	Columbus	Mississippi
United States	Crystal Rivers Dialysis Center	Crystal River	Florida
United States	Atlanta Nephrology Referral Center	Decatur	Georgia
United States	Henry Ford Hospital	Detroit	Michigan
United States	Medical Nephrology Associates	Dyersburg	Tennessee
United States	Hypertension and Nephrology Associates	Eatontown	New Jersey
United States	Horizon Healthcare Associates	Flossmoor	Illinois
United States	Gadsden Dialysis	Gadsden	Alabama
United States	Renal Research Inc. at the Kidney Institute	Houston	Texas
United States	Outcomes Research International, Inc.	Hudson	Florida
United States	Indiana University Hospital	Indianapolis	Indiana
United States	Lewiston Dialysis Center	Lewistown	Pennsylvania
United States	FMC Marietta	Marietta	Georgia
United States	Winthrop University Dialysis Center	Mineola	New York
United States	Holy Cross Renal Care	Mission Hills	California
United States	Nephrology Associates, P.C.	Nashville	Tennessee
United States	Ochsner Clinic Foundation, Nephrology Research	New Orleans	Louisiana
United States	Clinical Research of Tidewater	Norfolk	Virginia
United States	Virginia Commonwealth University, Division of Nephrology	Richmond	Virginia
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Nephrology Educational Services and Research	Tarzana	California
United States	Nephrology & Hypertension Associates, LTD	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Up to 24 weeks	No
Primary	Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals		Up to 24 weeks	Yes
Secondary	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		Up to 24 weeks	No