Kidney Information Network for Disease Research and Education

End Stage Renal Disease Clinical Trial

— KINDRED  

Official title:

Kidney Information Network for Disease Research and Education (KINDRED)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03321604
• Other study ID #: 2016P002671
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• ESRD
• Fabry Disease
• Genetic Diseases, Inborn
• Genetic Diseases, X-Linked
• Kidney Diseases
• Kidney Failure, Chronic
• Rare Diseases

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

External Links

•   KINDRED Website