Kidney Information Network for Disease Research and Education

Terminated

• Conditions: Genetic Diseases, X-Linked; Fabry Disease; End Stage Renal Disease; Kidney Diseases; ESRD; Rare Diseases

• Registration Number: NCT03321604
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Study Start: 2018-01-01
• Primary Completion: 2019-11-21
• Study Completion: 2019-11-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Adults between 18 and 65 with ESRD undergoing dialysis.

Exclusion Criteria

• Kidney biopsy unlikely to be Fabry disease; those with a diagnosis that is clinically or biochemically proven not to be Fabry disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States