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Trial record 43 of 99 for:    polycystic kidney disease
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ADPKD Cohort Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
PKD Foundation
Information provided by (Responsible Party):
Arlene Chapman, MD, Emory University
ClinicalTrials.gov Identifier:
NCT02084849
First received: March 10, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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.


Condition
Autosomal Dominant Polycystic Kidney Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 84 Months
Official Title: The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in GFR as compared to change in renal volume over time [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in the ability to determine change in renal volume over time between MRI and ultrasound [ Time Frame: Three years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, urine, tissue
Estimated Enrollment: 1000
Study Start Date: June 1998
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084849

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
PKD Foundation
Investigators
Principal Investigator: Arlene Chapman, MD Emory University
  More Information

No publications provided

Responsible Party: Arlene Chapman, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02084849     History of Changes
Other Study ID Numbers: IRB00041117, 0247-1998
Study First Received: March 10, 2014
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
 Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on March 03, 2015