Pilotstudie zur Pyridoxalphosphattherapie bei Patienten mit primärer Hyperoxalurie Typ I - Pilot trial on treatment of patients with primary hyperoxaluria type I with pyridoxal-phosphate

• Conditions: In this study we 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.; MedDRA version: 12.1Level: LLTClassification code 10037671Term: Pyridoxine deficiency

• Registration Number: EUCTR2009-015217-52-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-12
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•The drug-response-relationship of pyridoxal-phosphate will be checked by repeated measurements of the serum pyridoxal-phosphate levels
• Reduction of the plasma oxalate level as change in plasma oxalate concentration from baseline to week 6, 12, 18 and 24
•Reduction of the urinary oxalate excretion in patients with PH I at weeks 6, 12, 18 compared to baseline.
•The safety of the oral application of an i.v. pyridoxal-phosphate solution will be determined.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or lactating women
•Women of child-bearing potential who are not using a highly effective contraception method with a pearl-index < 1. Highly effective contraception methods are oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, or sterile sexual partner and must agree to continue using such precautions during the pyridoxal-phosphate study.
•Subjects post liver or kidney transplantation or combined transplantation
•Chronic diarrhoea with the risk of malabsorption
•Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator, is indicative of a disease that would compromise the safety taking pyridoxal-phosphate per os and the absorption.
•Subjects participating in other clinical trials with investigational products 4 weeks prior to trial entry, during the trial and 4 weeks after the trial
•Subjects who are unable to take the trial medication
•Subjects who are unable to collect 24-hour urine samples or follow other study procedures
•Subjects who are under treatment with L-Dopa, Isoniazid, D-Penicillamine (interactions between these drugs and pyridoxal-phosphate are known and might influence serum pyridoxal-phosphate levels)
•Subjects with known allergies to substances of contents (e.g. Potassiumsorbet, raspberry sirupe)
•Subjects confined to an institution on judicial or official behalf.
•Subjects who are in dependency to the sponsor or the PI of the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified