An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

June 14, 2016 updated by: Genzyme, a Sanofi Company

A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease

Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

  • Evaluate the safety and tolerability of sevelamer carbonate
  • Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Investigational Site Number 8101
      • Bron, France, 69677
        • Investigational Site Number 8102
      • Paris Cedex 19, France, 75935
        • Investigational Site Number 8103
  • Germany
      • Berlin, Germany, 13353
        • Investigational Site Number 8201
      • Marburg, Germany, 35033
        • Investigational Site Number 8202
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Investigational Site Number 8302
      • Vilnius, Lithuania, 08406
        • Investigational Site Number 8301
  • Poland
      • Gdansk, Poland
        • Investigational Site Number 8402
      • Krakow, Poland, 301-663
        • Investigational Site Number 8401
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 8003
      • Birmingham, Alabama, United States, 35205
        • Investigational Site Number 8005
    • California
      • Los Angeles, California, United States, 90024
        • Investigational Site Number 8013
      • San Francisco, California, United States, 94143
        • Investigational Site Number 8014
    • Florida
      • Orlando, Florida, United States, 32806
        • Investigational Site Number 8025
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Investigational Site Number 8007
    • Iowa
      • Iowa City, Iowa, United States
        • Investigational Site Number 8019
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Investigational Site Number 8012
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigational Site Number 8008
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigational Site Number 8020
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Investigational Site Number 8022
      • St Louis, Missouri, United States, 63110
        • Investigational Site Number 8023
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Investigational Site Number 8017
    • New York
      • Buffalo, New York, United States, 14222
        • Investigational Site Number 8018
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Investigational Site Number 8009
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Investigational Site Number 8010
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigational Site Number 8011
    • Texas
      • Dallas, Texas, United States, 75390
        • Investigational Site Number 8026
      • Houston, Texas, United States, 77030
        • Investigational Site Number 8016
      • San Antonio, Texas, United States, 78229
        • Investigational Site Number 8001
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Investigational Site Number 8002
      • Richmond, Virginia, United States, 23298-0034
        • Investigational Site Number 8027
    • Washington
      • Seattle, Washington, United States, 98105
        • Investigational Site Number 8006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.
  • The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.

Exclusion Criteria:

  • The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.
  • The participant had a non-renal case of hyperphosphatemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).
Drug: Placebo
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
Drug: Sevelamer carbonate
0.8 g sachets of powder for oral suspension or 800 mg tablets
Other Names:
  • Renvela®
Experimental: FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.
Drug: Placebo
Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
Drug: Sevelamer carbonate
0.8 g sachets of powder for oral suspension or 800 mg tablets
Other Names:
  • Renvela®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Time Frame: Baseline, Week 2
Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
Baseline, Week 2
Treatment - Emergent Adverse Events (AEs)
Time Frame: Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
Time Frame: Baseline, Week 28/Early Termination
Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.
Baseline, Week 28/Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SVCARB07609
  • 2011-002329-23 (EudraCT Number)
  • DRI12793 (Other Identifier: Genzyme Corporation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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