Clinical Trial: A Comparison of Lanthanum Carbonate and Calcium Carbonate in Children
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official 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 Us
Brief Summary: To provide information about the safety and efficacy of lanthanum carbonate in children compared to standard treatment.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus [ Time Frame: 8 Weeks ]
Original Primary Outcome: Same as current
Current 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 ]
Original 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 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Calcium Levels at up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from baseline in Calcium-Phosphorous Product at up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from baseline in Bone Alkaline Phosphatase (ALP) at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Tartrate-Resistant Acid Phosphatase (TRAP) at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline Osteocalcin levels at Up to 12 [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Fibroblast Growth factor 23 (FGF-23) Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Parathyroid Hormone (PTH) Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Sclerostin Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Fetuin-A Levels at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Height at up to 12 Months [ Time Frame: Baseline and up to 12 months ]
- Change from Baseline in Weight at Up to 12 Months [ Time Frame: Baseline and up to 12 months ]
Information By: Shire
Dates:
Date Received: September 26, 2012
Date Started: February 11, 2013
Date Completion: July 9, 2018
Last Updated: January 25, 2017
Last Verified: January 2017