Phase
Condition
Kidney Failure (Pediatric)
Kidney Failure
Kidney Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 recentconsecutive 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 atscreening
Have not participated in any other investigational drug studies within 30 days priorto enrollment
Level of understanding and willingness to cooperate with all visits and procedures asdescribed by the study personnel
Willing and able to take sevelamer alone as a phosphate binder for the duration of thestudy
Willing and able to maintain screening doses of lipid medication for the duration ofthe 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 anevening 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 includesbarrier methods, hormones, or intrauterine devices (IUDs)
Life expectancy of 12 months or greater
Willing and able to provide informed consent
Exclusion
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 clinicallysignificant unstable medical condition
Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia orseizure 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 thesubject's inclusion in the study
Study Design
Connect with a study center
Clinical Research Center
Birmingham, Alabama 35213
United StatesSite Not Available
Gadsden Dialysis
Gadsden, Alabama 35901
United StatesSite Not Available
Holy Cross Renal Care
Mission Hills, California 91345
United StatesSite Not Available
Nephrology Educational Services and Research
Tarzana, California 91356
United StatesSite Not Available
Crystal Rivers Dialysis Center
Crystal River, Florida 34429
United StatesSite Not Available
Outcomes Research International, Inc.
Hudson, Florida 34667
United StatesSite Not Available
Central Dialysis Center
Atlanta, Georgia 30329
United StatesSite Not Available
Atlanta Nephrology Referral Center
Decatur, Georgia 30030
United StatesSite Not Available
FMC Marietta
Marietta, Georgia 30066
United StatesSite Not Available
Horizon Healthcare Associates
Flossmoor, Illinois 60422
United StatesSite Not Available
Indiana University Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
Ochsner Clinic Foundation, Nephrology Research
New Orleans, Louisiana 70121
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Southwest Mississippi Nephrology, PLLC
Brookhaven, Mississippi 39601
United StatesSite Not Available
Nephrology Associates, P.C.
Columbus, Mississippi 39705
United StatesSite Not Available
Nephrology & Hypertension Associates, LTD
Tupelo, Mississippi 38801
United StatesSite Not Available
Washington University School of Medicine
St. Louis, Missouri 63110
United StatesSite Not Available
Hypertension and Nephrology Associates
Eatontown, New Jersey 07724
United StatesSite Not Available
Davita
Bronx, New York 10461
United StatesSite Not Available
Winthrop University Dialysis Center
Mineola, New York 11501
United StatesSite Not Available
Kidney and Hypertension Center
Cincinnati, Ohio 45220
United StatesSite Not Available
Renal Care Group
Cleveland, Ohio 44109
United StatesSite Not Available
Lewiston Dialysis Center
Lewistown, Pennsylvania 17044
United StatesSite Not Available
Medical Nephrology Associates
Dyersburg, Tennessee 38024
United StatesSite Not Available
Nephrology Associates, P.C.
Nashville, Tennessee 37205
United StatesSite Not Available
Renal Research Inc. at the Kidney Institute
Houston, Texas 77054
United StatesSite Not Available
Gambro Healthcare - Charlottesville
Charlottesville, Virginia 22902
United StatesSite Not Available
Clinical Research of Tidewater
Norfolk, Virginia 23507
United StatesSite Not Available
Virginia Commonwealth University, Division of Nephrology
Richmond, Virginia 23298
United StatesSite Not Available
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