RecruitingACTRN12606000380594
An Open Label, Dose Titration Study Of Sevelamer Carbonate Dosed Three Times A Day In Hyperphosphatemic Chronic Kidney Disease (CKD) Patients Not On Dialysis
An Open Label, Dose Titration Study of Sevelamer Carbonate dosed Three Times A Day in the control of phosphorus levels in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
Sponsor
Genzyme Corporation, USA
Enrollment
40 participants
Start Date
Jan 1, 2006
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- CKD patients not on dialysis; documented hyperphosphatemia without the use of a phosphate binder or after washout from current phosphate binder; signed informed consent.
Exclusion Criteria1
- Known hypersensitivity to the investigational product or any constituents of the study drug; active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders; in the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition; 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.
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Interventions
This study will test an 8-week treatment course of the investigational drug Sevelamer Carbonate, at doses from 4.8g up to 12g orally daily, in patients with Hyperphosphatemic CKD not on dialysis.
This study will test an 8-week treatment course of the investigational drug Sevelamer Carbonate, at doses from 4.8g up to 12g orally daily, in patients with Hyperphosphatemic CKD not on dialysis.
Locations(1)
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ACTRN12606000380594