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

Primary Purpose

Chronic Kidney Disease, Chronic Kidney Disease on Hemodialysis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebo
Sevelamer carbonate
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sevelamer carbonate

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs.

Secondary Outcome Measures

Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).

Full Information

First Posted
November 26, 2012
Last Updated
March 19, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01736150
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Chronic Kidney Disease on Hemodialysis
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevelamer carbonate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Renvela
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
Time Frame
8 weeks
Title
Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs.
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
Country
China
Facility Name
West China Hospital
City
Chengdu
Country
China
Facility Name
Southwest Hospital
City
Chongqing
Country
China
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
Country
China
Facility Name
Sun Yat-Sen University School of Medicine 1st Affiliated Hospital
City
Guangzhou
Country
China
Facility Name
Zhejiang University School of Medicine 1st Affiliated Hospital
City
Hangzhou
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
Zhongda Hospital of Southeast University
City
Nanjing
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
Country
China
Facility Name
Changzheng Hospital
City
Shanghai
Country
China
Facility Name
Renji Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Xinhua Hospital
City
Shanghai
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Facility Name
Wenzhou College of Medicine 1st Affiliated Hospital
City
Wenzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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