COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

ADPKD Patient Registry (ADPKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04039061
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 9, 2019
Information provided by (Responsible Party):
PKD Foundation

Tracking Information
First Submitted Date July 29, 2019
First Posted Date July 31, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date September 4, 2019
Estimated Primary Completion Date September 4, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2019)
Number of people with polycystic kidney disease who experience health-related quality-of-life changes [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title ADPKD Patient Registry
Official Title Autosomal Dominant Polycystic Kidney Disease Patient Registry
Brief Summary

The purpose of the ADPKD Registry is to create an online patient network that includes at least 5,000 people with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who contribute data on their health and other topics. The ADPKD Patient Registry aims to support important scientific discoveries and support patient needs in the following ways:

  • Connect ADPKD patients with opportunities to join clinical studies.
  • Collect data for the research community to better describe the ADPKD disease experience and improve patient care.
  • Engage with patients by measuring quality of life outcomes.
Detailed Description

The ADPKD Registry will be a patient-powered network of people with ADPKD. This data will inform new research to improve ADPKD patient outcomes, learn more about the patient journey and discover unmet medical needs. We collect data most relevant to your ADPKD diagnosis, its major symptoms and management, as well as key demographic data (no personally identifiable information is shared). A Registry keeps information in one place making it easier for researchers to utilize Registry information while still protecting the privacy of those who take part. The Registry will be hosted on a secure, online platform that patients can access using their home computers, tablets or phones.

The purpose of the ADPKD Registry is to allow PKD patients to:

  • Connect with researchers and express interest in taking part in certain clinical studies for ADPKD, including studies of new medications and other treatments.
  • Take confidential health-related surveys. These surveys are aimed at better understanding of the health of people with PKD across their lifespans.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Anyone with ADPKD, or suspects that they have ADPKD, is welcome to participate
Condition Polycystic Kidney Diseases
Intervention Not Provided
Study Groups/Cohorts ADPKD patients
Patients with a diagnosis, or suspected diagnosis, of ADPKD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 29, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 4, 2029
Estimated Primary Completion Date September 4, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis or suspected diagnosis with autosomal dominant polycystic kidney disease (ADPKD)

Exclusion Criteria:

  • caretakers, family members or friends of individuals with ADPKD
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contact: Elise Hoover 816-268-8478
Contact: Registry staff
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04039061
Other Study ID Numbers 120190065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party PKD Foundation
Study Sponsor PKD Foundation
Collaborators Not Provided
Investigators Not Provided
PRS Account PKD Foundation
Verification Date September 2019