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Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease

Recruiting
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
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

Key

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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Part A: Percentage of PKD1 Gene Variant Groups in the ADPKD PopulationGenotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day)
Part A: Weight of Participants Within Each PKD1 Gene Variant GroupGenotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day)
Part A: Height of Participants Within Each PKD1 Gene Variant GroupGenotyping 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 GroupGenotyping 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 GroupGenotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (31)

Charité - Paediatric Pulmonology Department

🇩🇪

Berlin, Germany

UMCG - Nephrology

🇳🇱

Groningen, Netherlands

Alabama Kidney Research

🇺🇸

Alabaster, Alabama, United States

Kaiser Permanente - Los Angeles Medical Center

🇺🇸

Los Angeles, California, United States

Nephrology & Hypertension Associates, PC

🇺🇸

Middlebury, Connecticut, United States

Yale Nephrology Clinical Research Clinic

🇺🇸

New Haven, Connecticut, United States

Nature Coast Clinical Research - Inverness

🇺🇸

Inverness, Florida, United States

Emory School of Medicine - Renal Division

🇺🇸

Atlanta, Georgia, United States

Renal Associates, LLC

🇺🇸

Columbus, Georgia, United States

University of Iowa Hospital & Clinics

🇺🇸

Iowa City, Iowa, United States

Scroll for more (21 remaining)
Charité - Paediatric Pulmonology Department
🇩🇪Berlin, Germany

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