Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis
A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis
1 other identifier
interventional
205
1 country
18
Brief Summary
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 dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedMarch 23, 2015
March 1, 2015
6 months
November 26, 2012
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).
8 weeks
Study Arms (2)
Sevelamer carbonate
EXPERIMENTALSubjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.
Placebo
PLACEBO COMPARATORSubjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.
Interventions
* Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.
* Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2012
First Posted
November 29, 2012
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 23, 2015
Record last verified: 2015-03