Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Kidney Diseases, Chronic Renal Insufficiency, End-Stage Renal Disease
About this trial
This is an interventional treatment trial for Kidney Diseases focused on measuring Chronic, Hemodialysis, Kidney, Hyperphosphatemia, Chronic kidney disease, Chronic Renal Insufficiency
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
Sites / Locations
- Clinical Research Center
- Gadsden Dialysis
- Holy Cross Renal Care
- Nephrology Educational Services and Research
- Crystal Rivers Dialysis Center
- Outcomes Research International, Inc.
- Central Dialysis Center
- Atlanta Nephrology Referral Center
- FMC Marietta
- Horizon Healthcare Associates
- Indiana University Hospital
- Ochsner Clinic Foundation, Nephrology Research
- Henry Ford Hospital
- Southwest Mississippi Nephrology, PLLC
- Nephrology Associates, P.C.
- Nephrology & Hypertension Associates, LTD
- Washington University School of Medicine
- Hypertension and Nephrology Associates
- Davita
- Winthrop University Dialysis Center
- Kidney and Hypertension Center
- Renal Care Group
- Lewiston Dialysis Center
- Medical Nephrology Associates
- Nephrology Associates, P.C.
- Renal Research Inc. at the Kidney Institute
- Gambro Healthcare - Charlottesville
- Clinical Research of Tidewater
- Virginia Commonwealth University, Division of Nephrology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
sevelamer carbonate powder
Sevelamer hydrochloride