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

• 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: Genzyme, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Genzyme, a Sanofi Company )

Tracking Information

• First Submitted Date: April 6, 2012
• First Posted Date: April 10, 2012
• Results First Submitted Date: June 14, 2016
• Results First Posted Date: July 25, 2016
• Last Update Posted Date: July 25, 2016
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Hyperphosphatemia
• Chronic Kidney Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 19, 2015): 101
• Original Estimated Enrollment (submitted: April 6, 2012): 100
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Lithuania, Poland, United States
• Removed Location Countries: Turkey

Administrative Information

• NCT Number: NCT01574326
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
• Study Sponsor: Genzyme, a Sanofi Company
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Genzyme, a Sanofi Company

• PRS Account: Sanofi
• Verification Date: June 2016