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

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. Potassium sorbet, raspberry syrup)
• •Subjects confined to an institution on judicial or official behalf
• •Subjects who are in dependency to the sponsor or the PI of the trial