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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Chronic Kidney Disease on Hemodialysis
• Intervention / Treatment: Drug: Sevelamer carbonate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Chengdu, China
    • Sichuan Provincial People's Hospital
  • Chengdu, China
    • West China Hospital
  • Chongqing, China
    • Southwest Hospital
  • Guangzhou, China
    • Nanfang Hospital
  • Guangzhou, China
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China
    • Sun Yat-Sen University School of Medicine 1st Affiliated Hospital
  • Hangzhou, China
    • Zhejiang University School of Medicine 1st Affiliated Hospital
  • Nanjing, China
    • Jiangsu Province Hospital
  • Nanjing, China
    • Zhongda Hospital of Southeast University
  • Qingdao, China
    • Qingdao Municipal Hospital
  • Shanghai, China
    • ZhongShan Hospital
  • Shanghai, China
    • Renji Hospital
  • Shanghai, China
    • Shanghai Ruijin Hospital
  • Shanghai, China
    • Xinhua Hospital
  • Shanghai, China
    • Changzheng hospital
  • Wenzhou, China
    • Wenzhou College of Medicine 1st Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Renvela
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 26, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Estimate): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: SVCARB03808