ADPKD Cohort Study

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

Official title:

The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084849
• Other study ID #: IRB00041117
• Secondary ID: 0247-1998
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: June 23, 2015
• Start date: June 1998
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	PKD Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in GFR as compared to change in renal volume over time		Three years	No
Secondary	Differences in the ability to determine change in renal volume over time between MRI and ultrasound		Three years	No