Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Capable and willing to provide written informed consent or assent
Documented diagnosis of PH1 or PH2, confirmed by genotyping
Must meet the 24 hour urine oxalate excretion requirements
Less than 20% variation between the two 24-hour urinary creatinine excretion values derived from the two 24-hour urine collections in the screening period
Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 BSA
You may not be if
Renal or hepatic transplantation (prior or planned within the study period)
Currently on dialysis or anticipated requirement for dialysis during the study period
Plasma oxalate \>30 µmol/L
Documented evidence of clinical manifestations of systemic oxalosis (including pre-existing retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
Use of an RNA interference (RNAi) drug within the last 6 months
Participation in any clinical study in which you received an investigational medicinal product (IMP) within 4 months before Screening
Liver function test (LFT) abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 times upper limit of normal (ULN) for age and gender
Inability or unwillingness to comply with study procedures
