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

Phase 3

Completed

• Conditions: Chronic Kidney Disease on Hemodialysis; Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: Sevelamer carbonate

• Registration Number: NCT01736150
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects 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.
Sevelamer carbonate	Sevelamer carbonate	Subjects 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).	8 weeks

Trial Locations

Locations (18)

Zhongda Hospital of Southeast University; 🇨🇳 Nanjing, China

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

West China Hospital; 🇨🇳 Chengdu, China

Southwest Hospital; 🇨🇳 Chongqing, China

Zhejiang University School of Medicine 1st Affiliated Hospital; 🇨🇳 Hangzhou, China

Nanfang Hospital; 🇨🇳 Guangzhou, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

Guangzhou First Municipal People's Hospital; 🇨🇳 Guangzhou, China

Sun Yat-Sen University School of Medicine 1st Affiliated Hospital; 🇨🇳 Guangzhou, China

Wenzhou College of Medicine 1st Affiliated Hospital; 🇨🇳 Wenzhou, China

Qingdao Municipal Hospital; 🇨🇳 Qingdao, China

Changzheng Hospital; 🇨🇳 Shanghai, China

Renji Hospital; 🇨🇳 Shanghai, China

Xinhua Hospital; 🇨🇳 Shanghai, China

Zhongshan Hospital; 🇨🇳 Shanghai, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, China

Peking University First Hospital; 🇨🇳 Beijing, China