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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03321604
Other study ID # 2016P002671
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date November 21, 2019

Study information

Verified date February 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 338
Est. completion date November 21, 2019
Est. primary completion date November 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital Genzyme, a Sanofi Company, Scott and White Hospital & Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Differences in patient characteristics of dialysis patients diagnosed with Fabry disease vs. dialysis patients who do not have Fabry disease. 5 years
Secondary 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
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