Clinical Trial: Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PILOTSTUDIE ZUR PYRIDOXALPHOSPHATTHERAPIE BEI PATIENTEN MIT PRIMÄRER HYPEROXALURIE TYP I (PHOX-B6-PILOT) Pilot Trial on Treatment of Patients With Primary Hyperoxaluria

Brief Summary: In this study the investigators will prospectively analyze the reduction of urinary oxalate excretion under the treatment with PLP in dosages of 5mg/kg/day up to 20 mg/kg/day and serum level response relationship with PLP as an i.v. solution used orally in 12 patients with primary hyperoxaluria type I as an inherited autosomal-recessive-disorder leading to increased endogenous oxalate production, urolithiasis and end stage renal disease.

Detailed Summary:
Sponsor: University of Cologne

Current Primary Outcome: The primary endpoint of the study is the reduction of the urinary oxalate excretion (percentage change in urinary oxalate, expressed as mmol/1.73 m2 /day) at week 24 compared to baseline. [ Time Frame: 6 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Cologne

Dates:
Date Received: January 20, 2011
Date Started: December 2010
Date Completion:
Last Updated: October 26, 2012
Last Verified: October 2012