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Clinical Trial Details

Trial ID: L0348
Source ID: NCT01736150
Associated Drug: Placebo
Title: Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Chronic Kidney Disease on Hemodialysis
Interventions: DRUG: Placebo|DRUG: Sevelamer carbonate
Outcome Measures: Primary: Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous., 8 weeks|Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs., 11 weeks | Secondary: Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol)., 8 weeks
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 205
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-03
Completion Date: 2010-09
Results First Posted:
Last Update Posted: 2015-03-23
Locations: Peking Union Medical College Hospital, Beijing, China|Peking University First Hospital, Beijing, China|Sichuan Provincial People's Hospital, Chengdu, China|West China Hospital, Chengdu, China|Southwest Hospital, Chongqing, China|Guangzhou First Municipal People's Hospital, Guangzhou, China|Nanfang Hospital, Guangzhou, China|Sun Yat-Sen University School of Medicine 1st Affiliated Hospital, Guangzhou, China|Zhejiang University School of Medicine 1st Affiliated Hospital, Hangzhou, China|Jiangsu Province Hospital, Nanjing, China|Zhongda Hospital of Southeast University, Nanjing, China|Qingdao Municipal Hospital, Qingdao, China|Changzheng Hospital, Shanghai, China|Renji Hospital, Shanghai, China|Shanghai Ruijin Hospital, Shanghai, China|Xinhua Hospital, Shanghai, China|Zhongshan Hospital, Shanghai, China|Wenzhou College of Medicine 1st Affiliated Hospital, Wenzhou, China
URL: https://clinicaltrials.gov/show/NCT01736150