Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006449

Trial Description

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Title

A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate Using a Crossover Design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 Years to <18 Years With Chronic Kidney Disease on Dialysis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To provide information about the safety and efficacy of lanthanum carbonate in children
compared to standard treatment.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006449
  •   2015/03/11
  •   2012/09/26
  •   no
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Secondary IDs

  •   2012-000171-17 
  •   NCT01696279  (ClinicalTrials.gov)
  •   SPD405-207  (Shire)
  •   2012-000171-17 
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Health Condition or Problem studied

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

  •   Drug: Lanthanum carbonate
  •   Drug: Calcium carbonate
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Crossover
  •   II
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Primary Outcome

- Percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus; time frame: 8 Weeks

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Secondary Outcome

- Change from baseline in serum phosphorus at up to 8 weeks; time frame: Baseline and up to 8 weeks
- Change from Baseline in Calcium Levels at up to 8 weeks; time frame: Baseline and up to 8 weeks
- Change from baseline in Calcium-Phosphorous Product at up to 8 Weeks; time frame: Baseline and up to 8 weeks
- Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate; time frame: over 48 hours post-dose on Day 1
- Area Under the Plasma Concentration-Time Curve from time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Lanthanum Carbonate; time frame: over 48 hours post-dose on Day 1
- Change from baseline in serum phosphorus at up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Calcium Levels at up to 10 Months; time frame: Baseline and up to 10 months
- Change from baseline in Calcium-Phosphorous Product at up to 10 Months; time frame: Baseline and up to 10 months
- Change from baseline in Bone Alkaline Phosphatase (ALP) at Up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Tartrate-Resistant Acid Phosphatase (TRAP) at Up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline Osteocalcin levels at Up to 10; time frame: Baseline and up to 10 months
- Change from Baseline in Fibroblast Growth factor 23 (FGF-23) Levels at Up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Parathyroid Hormone (PTH) Levels at Up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Sclerostin Levels at Up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Fetuin-A Levels at Up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Height at up to 10 Months; time frame: Baseline and up to 10 months
- Change from Baseline in Weight at Up to 10 Months; time frame: Baseline and up to 10 months

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Countries of Recruitment

  •   Argentina
  •   Bulgaria
  •   Chile
  •   Czech Republic
  •   Germany
  •   Hungary
  •   Poland
  •   Romania
  •   Russian Federation
  •   Turkey
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Locations of Recruitment

  •  
  •  
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Recruitment

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  •   2013/02/27
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   17   Years
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Additional Inclusion Criteria

1. Aged 10 years to less than 18 years of age at the time of consent

2. Serum phosphorus levels as follows:

- Age less than 12 years: Serum phosphorus greater than 6.0 mg/dL (1.94 mmol/L)

- Age 12 years and older: Serum phosphorus greater than 5.5 mg/dL (1.78 mmol/L)

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Exclusion Criteria

1. Unable to eat semi-solid foods or on Total Enteral Alimentation

2. Serum PTH greater than 700 pg/mL

3. Serum calcium greater than 10.2 mg/dL (2.54 mmol/L)

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Addresses

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    • Shire
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    • Hannover Medical School
    • Dieter Haffner, Prof 
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    • Shire Call Centre 
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    •   +1 866 842 5335
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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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.