The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum
phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on
Drug: Sevelamer carbonate
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01736150
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a
Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition
All locations for NCT01736150
Peking Union Medical College Hospital
Peking University First Hospital
Sichuan Provincial People's Hospital
West China Hospital
Guangzhou First Municipal People's Hospital
Sun Yat-Sen University School of Medicine 1st Affiliated Hospital
Zhejiang University School of Medicine 1st Affiliated Hospital
Jiangsu Province Hospital
Zhongda Hospital of Southeast University
Qingdao Municipal Hospital
Shanghai Ruijin Hospital
Wenzhou College of Medicine 1st Affiliated Hospital
View full eligibility
Tris trial is registered with FDA with number: NCT01736150. The sponsor of the trial is Genzyme, a Sanofi Company and it is looking for 205 volunteers for the current phase.
Official trial title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis
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