drugset / Trial / NCT01281878
Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyridoxal 5'-Phosphate | Unknown | 20 mg/kg | Oral |