ADPKD Cohort Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in GFR as compared to change in renal volume over time

Time frame: Three years

Secondary outcomes

Differences in the ability to determine change in renal volume over time between MRI and ultrasound

Time frame: Three years

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

PKD Foundation

Registry information

Official study title

The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study

Important dates

Study start: 1998
Primary completion: 2015
Study completion: 2015
First posted: Mar 12, 2014
Registry last updated: Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed