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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 12 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06747572
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vertex Pharmaceuticals Incorporated
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Puerto Rico, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Alabama Kidney Research, Alabaster, Alabama

Status

Recruiting

Address

Alabama Kidney Research

Alabaster, Alabama, 35007

Los Angeles, California

Status

Recruiting

Address

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90027

DaVita Clinical Research, Middlebury, Connecticut

Status

Recruiting

Address

DaVita Clinical Research

Middlebury, Connecticut, 06762

Yale Nephrology Clinical Research Clinic, New Haven, Connecticut

Status

Recruiting

Address

Yale Nephrology Clinical Research Clinic

New Haven, Connecticut, 06510

Inverness, Florida

Status

Recruiting

Address

Nature Coast Clinical Research - Inverness

Inverness, Florida, 34452

Atlanta, Georgia

Status

Recruiting

Address

Emory School of Medicine - Renal Division

Atlanta, Georgia, 30308

Renal Associates, LLC, Columbus, Georgia

Status

Recruiting

Address

Renal Associates, LLC

Columbus, Georgia, 31904

University of Iowa Hospital & Clinics, Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospital & Clinics

Iowa City, Iowa, 52242

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Tufts Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Quest Research Institute, Farmington Hills, Michigan

Status

Recruiting

Address

Quest Research Institute

Farmington Hills, Michigan, 48334

DaVita Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

DaVita Clinical Research

Las Vegas, Nevada, 89107

International Sites

Hopital de la Cavale Blanche, Brest, France

Status

Recruiting

Address

Hopital de la Cavale Blanche

Brest, ,

FDI Clinicial Research, San Juan, Puerto Rico

Status

Recruiting

Address

FDI Clinicial Research

San Juan, ,

Royal Free NHS Trust, London, United Kingdom

Status

Recruiting

Address

Royal Free NHS Trust

London, ,