Clinical trial NCT01736150: Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Chronic Kidney Disease on Hemodialysis
Keywords: Hemodialysis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
timeFrame: 8 weeks
measure: Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs.
timeFrame: 11 weeks
Secondary outcomes:
measure: Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: West China Hospital
city: Chongqing
country: China
facility: Southwest Hospital
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University School of Medicine 1st Affiliated Hospital
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine 1st Affiliated Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Zhongda Hospital of Southeast University
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Changzheng Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Shanghai
country: China
facility: Xinhua Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Wenzhou
country: China
facility: Wenzhou College of Medicine 1st Affiliated Hospital
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: