Active — Not RecruitingNot Applicable

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

United States401 participantsStarted 2024-12-19

Plain-language 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.

Who can participate

Age range12 Years – 65 Years

SexALL

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Key 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.

What they're measuring

Part A: Percentage of PKD1 Gene Variant Groups in the ADPKD Population

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Genotyping Visit on Day 1 of Part A (Part A duration: 1 Calendar Day)

Trial details

NCT IDNCT06747572

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Autosomal Dominant Polycystic Kidney Disease (ADPKD) trials