NCT02161068

Brief Summary

This is a retrospective analysis to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of ADPKD and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

7.9 years

First QC Date

April 23, 2014

Last Update Submit

February 28, 2022

Conditions

ADPKD

Keywords

ADPKDChart ReviewPKD Genotyping

Outcome Measures

Primary Outcomes (1)

  • Natural history of ADPKD

    Retrospective review to determine clinical, genetic, and radiographic characteristics that may influence the incidence of renal and extrarenal complications of ADPKD and prospective PKD genotyping if not previously performed.

    Up to 11 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients enrolled in this study will have the diagnosis of ADPKD

You may qualify if:

  • Subjects should have a confirmed ADPKD diagnosis.

You may not qualify if:

  • Unable to provide informed consent for PKD Genotyping.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

After informed consent is obtained, blood samples for PKD genotyping will be obtained from the study patient. Genotype results will be made available to the patient and they will be referred to a genetic counselor at their request. This service would not be a part of the study and therefore, genetic counseling would be done at the patient's expense.

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Jon Blumenfeld, MD

    The Rogosin Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

June 11, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

US(1)