Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With Chronic Kidney Disease on Hemodialysis

Condition(s) targeted: Kidney Diseases; Chronic Renal Insufficiency; End-Stage Renal Disease

Intervention: sevelamer carbonate (2.4g) (Drug); Renagel® Tablets (sevelamer hydrochloride) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Genzyme

Official(s) and/or principal investigator(s):
Jeremy Heaton, M.D., Study Director, Affiliation: Genzyme

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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

Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

1. Two most recent consecutive serum phosphorus measurements that are ≥ 3. 0 and ≤ 6. 5 (6. 5) mg/dL within 60 days of screening

2. A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening

- Have the following central laboratory measurements:

1. A serum phosphorus measurement > 5. 5 mg/dL at randomization (Week 0)

2. 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

Gadsden Dialysis, Gadsden, Alabama 35901, United States

Clinical Research Center, Birmingham, Alabama 35213, United States

Nephrology Educational Services and Research, Tarzana, California 91356, United States

Holy Cross Renal Care, Mission Hills, California 91345, United States

Crystal Rivers Dialysis Center, Crystal River, Florida 34429, United States

Outcomes Research International, Inc., Hudson, Florida 34667, United States

FMC Marietta, Marietta, Georgia 30066, United States

Central Dialysis Center, Atlanta, Georgia 30329, United States

Atlanta Nephrology Referral Center, Decatur, Georgia 30030, United States

Horizon Healthcare Associates, Flossmoor, Illinois 60422, United States

Indiana University Hospital, Indianapolis, Indiana 46202, United States

Ochsner Clinic Foundation, Nephrology Research, New Orleans, Louisiana 70121, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Nephrology Associates, P.C., Columbus, Mississippi 39705, United States

Nephrology & Hypertension Associates, LTD, Tupelo, Mississippi 38801, United States

Southwest Mississippi Nephrology, PLLC, Brookhaven, Mississippi 39601, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Hypertension and Nephrology Associates, Eatontown, New Jersey 07724, United States

Winthrop University Dialysis Center, Mineola, New York 11501, United States

Davita, Bronx, New York 10461, United States

Kidney and Hypertension Center, Cincinnati, Ohio 45220, United States

Renal Care Group, Cleveland, Ohio 44109, United States

Lewiston Dialysis Center, Lewistown, Pennsylvania 17044, United States

Nephrology Associates, P.C., Nashville, Tennessee 37205, United States

Medical Nephrology Associates, Dyersburg, Tennessee 38024, United States

Renal Research Inc. at the Kidney Institute, Houston, Texas 77054, United States

Clinical Research of Tidewater, Norfolk, Virginia 23507, United States

Gambro Healthcare - Charlottesville, Charlottesville, Virginia 22902, United States

Virginia Commonwealth University, Division of Nephrology, Richmond, Virginia 23298, United States

Starting date: January 2006
Ending date: March 2007
Last updated: December 14, 2007