Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease
Purpose
The purpose of this study is to estimate the prevalence, demographic, and clinical characteristics of PKD1/2 gene variant groups in the ADPKD population.
Condition
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Eligibility
- Eligible Ages
- Between 12 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 30 milliliter per minute (mL/min)/1.73 m^2 - Willing and able to comply with scheduled visits and other study procedures - A pre-existing diagnosis of ADPKD as defined in the protocol
Exclusion Criteria
- History of kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD - History of solid organ or bone marrow transplantation or nephrectomy - Ongoing renal replacement therapy or planning to start renal replacement therapy less than or equal to (≤)12 months from the Genotyping Visit in Part A Other protocol defined Inclusion/Exclusion criteria will apply.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Part A | Eligible participants will complete a single visit to complete a blood sample collection for PKD1/2 genotyping. | |
| Part B | Participants who have completed all assessments in Part A and have a subset of variants in PKD1 will complete 1 year of follow-up. |
Recruiting Locations
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- Vertex Pharmaceuticals Incorporated