ADPKD Cohort Study

NCT ID: NCT02084849

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 624 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1998-06-30
• Study Completion Date: 2015-05-31

Brief Summary

The purpose of this study is to find out if radiology tests of the kidneys as opposed to glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function) follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for progression to renal failure (dialysis or transplantation) have been identified and include those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene (the inherited abnormality responsible for the majority of PKD), men as opposed to women, those with episodes of visible blood or increased protein in their urine, and women who have experience more than three pregnancies. Individuals who are diagnosed with PKD in the first year of life or in utero (before birth) are also at high risk for progression to renal failure.

This study will also facilitate understanding of human diseases at the cellular and molecular level. We will be identifying genetic factors that may influence the severity of polycystic kidney disease (PKD). You are being asked to provide a sample of blood for the purpose of DNA or other biochemical analyses.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Group 1 will consist of 300 ADPKD individuals who are early in the course of their disease and demonstrate risk factors for progression to ESRD.

No interventions assigned to this group

Group 2

Group 2 will consist of ADPKD subjects who have progressed to a more advanced stage of their renal disease. There is no limit with regard to the number of subjects to be recruited into this group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Group 1

• Hypertension diagnosed early in the course of the disease (less than 25 years for men; less than 30 years for women)
• ADPKD diagnosed in utero or in the first year of life
• The presence of proteinuria (between 180 mg and 1 gm/day) without evidence of a second renal disorder
• A history of more than 3 pregnancies and hypertension
• A history of gross hematuria
• A serum creatinine concentration less than 1.4 mg/dl
• ADPKD diagnosed in childhood with more than 10 cysts

Group 2

• Serum creatinine concentration >1.4 and
• Renal length greater than 15 cm and
• Age less than 60 years of age
• Severe pain or discomfort as assessed by the primary care physician related to ADPKD

Exclusion Criteria

• Subjects, who in the assessment of the principal investigator cannot provide reliable follow-up
• Subjects who cannot be exposed to iothalamate
• Subjects who cannot undergo MRI due to the presence of a pacemaker or surgical clip in the abdomen
• Subjects who are not anticipated to survive during the duration of the study (e.g. underlying malignancy)
• Subjects who cannot provide informed consent
• Women who are pregnant or who have undergone a pregnancy in the last 6 months or who are presently breastfeeding

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PKD Foundation

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Arlene Chapman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arlene Chapman, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

0247-1998

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00041117

Identifier Type: -

Identifier Source: org_study_id