drugset / Trial / NCT01281878

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

NCT01281878

Phase 2 Completed 12 enrolled University of Cologne
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-12
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyridoxal 5'-Phosphate Unknown 20 mg/kg Oral