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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01736150
Other study ID # SVCARB03808
Secondary ID
Status Completed
Phase Phase 3
First received November 26, 2012
Last updated March 19, 2015
Start date March 2010
Est. completion date September 2010

Study information

Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Placebo
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.
Sevelamer carbonate
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.

Locations

Country Name City State
China 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

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous. 8 weeks No
Primary Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs. 11 weeks Yes
Secondary Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol). 8 weeks No
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