ADPKD Cohort Study

NCT02084849 | Completed

• 2 other identifiers: IRB000411170247-1998
• Study Type: observational
• Target: 624
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Three years

Secondary Outcomes (1)

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

  Three years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ADPKD individuals at risk for progression to End Stage Renal Disease (ESRD)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• PKD Foundation: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, urine, tissue

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

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

Study Officials

• Arlene Chapman, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 84 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 12, 2014
• Study Start: June 1, 1998
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

US (1)