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Trial record 1 of 1 for:    DRI12793
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An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574326
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE June 14, 2016
Results First Posted Date  ICMJE July 25, 2016
Last Update Posted Date July 25, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
  • Change from Baseline to Visit 3 in serum phosphorus [ Time Frame: Baseline and Up to 6 weeks ]
  • Number of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 32 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
Change from Baseline to Visit 11/ET in serum phosphorus [ Time Frame: Baseline and 32 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Official Title  ICMJE 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
Brief Summary

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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperphosphatemia
  • Chronic Kidney Disease
Intervention  ICMJE
  • 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 Name: Renvela®
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Placebo
    • Drug: Sevelamer carbonate
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Sevelamer carbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2015)
101
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2012)
100
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Lithuania,   Poland,   United States
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT01574326
Other Study ID Numbers  ICMJE SVCARB07609
2011-002329-23 ( EudraCT Number )
DRI12793 ( Other Identifier: Genzyme Corporation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP