Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006482

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Objective: In hyperphosphatemic pediatric patients 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

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Brief Summary in Scientific Language

The study is 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.

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Organizational Data

  •   DRKS00006482
  •   2015/04/08
  •   2012/04/06
  •   no
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Secondary IDs

  •   2011-002329-23 
  •   NCT01574326  (ClinicalTrials.gov)
  •   SVCARB07609  (Genzyme, a Sanofi Company)
  •   2011-002329-23 
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Health Condition or Problem studied

  •   Hyperphosphatemia
  •   Chronic Kidney Disease
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: sevelamer carbonate
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- 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

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Secondary Outcome

- Change from Baseline to Visit 11/ET in serum phosphorus; time frame: Baseline and 32 Weeks

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Countries of Recruitment

  •   United States
  •   France
  •   Germany
  •   Lithuania
  •   Poland
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2012/05/31
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional Inclusion Criteria

- The patient has chronic kidney disease (CKD) requiring dialysis with an estimated
glomerular filtration rate (GFR) <60 mL/min/1.73m^2 based on central laboratory
results.

- The patient has a serum phosphorus level greater than the age appropriate upper limit
of normal based on central laboratory results.

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Exclusion Criteria

- The patient has active dysphagia, swallowing disorders or a predisposition to or
current bowel obstruction, ileus or severe gastrointestinal motility disorder(s)
including severe constipation, or major GI tract surgery.

- The patient has a non-renal case of hyperphosphatemia.

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Addresses

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    • Genzyme, a Sanofi Company
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    •   [---]*
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    • Genzyme, a Sanofi Company
    • Medical Monitor 
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    •   [---]*
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    • For site information, send an email with site number to 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Delmez J, Block G, Robertson J, Chasan-Taber S, Blair A, Dillon M, Bleyer AJ. A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clin Nephrol. 2007 Dec;68(6):386-91.; 18184521
  •   Fan S, Ross C, Mitra S, Kalra P, Heaton J, Hunter J, Plone M, Pritchard N. A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis. Nephrol Dial Transplant. 2009 Dec;24(12):3794-9. Epub 2009 Aug 7.; 19666658
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.