KINDRED: Kidney Information Network for Disease Research and Education

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03321604

Collaborator

Genzyme, a Sanofi Company (Industry), Scott and White Hospital & Clinic (Other)

338

Enrollment

Location

22.6

Actual Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data. Investigators will utilize data from the cohort to test the independent relationship between biochemical and genetic markers and Fabry disease and other rare diseases.

Condition or Disease	Intervention/Treatment	Phase
ESRD Fabry Disease Rare Diseases Kidney Diseases End Stage Renal Disease Genetic Diseases, X-Linked

Detailed Description

KINDRED is a prospective observational cohort study that will enroll up to 5,000 dialysis patients throughout the United States with and without known diagnosis of Fabry disease but at risk for Fabry disease (e.g., unknown cause of renal disease, young male, initiating dialysis without a kidney biopsy, etc).This tissue repository will allow for genetic screening of a geographically diverse population, assist in identification of rare diseases in ESRD, and collect research-quality information on risk factors and outcomes from an ethnically heterogeneous population of dialysis patients. In this study, Investigators will use a novel method of performing research in this population by leveraging the internet to enhance and accelerate recruitment of potential subjects to participate in a genetic screening/tissue repository protocol.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

338 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Kidney Information Network for Disease Research and Education (KINDRED)

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Nov 21, 2019

Actual Study Completion Date :

Nov 21, 2019

Outcome Measures

Primary Outcome Measures

Genetically determined Fabry disease prevalence amongst a heterogenous patient population with end-stage renal disease on dialysis in the US not previously known to have Fabry disease. [5 years]

Secondary Outcome Measures

Differences in patient characteristics of dialysis patients diagnosed with Fabry disease vs. dialysis patients who do not have Fabry disease. [5 years]
Differences in patient characteristics of individuals diagnosed with Fabry disease initiating dialysis after 2013 vs. patients with Fabry disease who started dialysis before 2003. [5 years]