Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736150
• Other study ID #: SVCARB03808
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Kidney Disease on Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

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