Autosomal Dominant Polycystic Kidney Disease (ADPKD) kidney disease
Conditions
Interventions
Labcorp PKD1 Sequencing AssayThe Labcorp PKD1 Sequencing Assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses gene-specific long-range PCR (LR-PCR) for target e
Sponsors
Labcorp Holdings, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Specimen Inclusion Criteria • Specimens must be human whole blood stored in K2EDTA (lavender top) tubes. • Specimens must be received within the acceptable temperature storage conditions. • Specimens must have appropriate information included to identify the specimens in accordance with the laboratory testing site requisition form/manual.
Exclusion criteria
Exclusion criteria: Specimen Exclusion Criteria • Specimen types other than human whole blood stored in K2EDTA. • Specimens received outside of the acceptable storage conditions. • Specimens received with suspected contamination. • Specimens with broken or damaged seals that would compromise the specimen integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives To evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV) Secondary Objectives • To evaluate the safety and tolerability of VX-407 • To evaluate the PK of VX-407 Exploratory Objectives • To evaluate the effect of VX-407 treatment on other kidney and liver imaging metrics observed on magnetic resonance imaging (MRI) • To evaluate exploratory biomarkers of polycystic kidney disease in blood and urine • To evaluate the effect of VX-407 on kidney function | — |
Secondary
| Measure | Time frame |
|---|---|
| see above | — |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactDC Craven
Labcorp Holdings, Inc.
Outcome results
None listed