Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Registration Number
- NCT06747572
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to estimate the prevalence, demographic, and clinical characteristics of PKD1/2 gene variant groups in the ADPKD population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
Key
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A: Percentage of PKD1 Gene Variant Groups in the ADPKD Population Genotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day) Part A: Weight of Participants Within Each PKD1 Gene Variant Group Genotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day) Part A: Height of Participants Within Each PKD1 Gene Variant Group Genotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day) Part A: Body Mass Index (BMI) of Participants Within Each PKD1 Gene Variant Group Genotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day) Part A: Age of Participants at ADPKD Diagnosis Within Each PKD1 Gene Variant Group Genotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (19)
Necker Hospital
🇫🇷Paris, France
Columbia University Medical Center
🇺🇸New York, New York, United States
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
King's College Hospital
🇬🇧London, United Kingdom
Sheffield Kidney Institute, Northern General Hospital
🇬🇧Sheffield, United Kingdom
Alabama Kidney Research
🇺🇸Alabaster, Alabama, United States
Kaiser Permanente - Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Emory School of Medicine - Renal Division
🇺🇸Atlanta, Georgia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Hopital de la Cavale Blanche
🇫🇷Brest, France
DaVita Clinical Research
🇺🇸Las Vegas, Nevada, United States
Yale Nephrology Clinical Research Clinic
🇺🇸New Haven, Connecticut, United States
Nature Coast Clinical Research - Inverness
🇺🇸Inverness, Florida, United States
Renal Associates, LLC
🇺🇸Columbus, Georgia, United States
University of Iowa Hospital & Clinics
🇺🇸Iowa City, Iowa, United States
FDI Clinicial Research
🇵🇷San Juan, Puerto Rico
Royal Free NHS Trust
🇬🇧London, United Kingdom