Kidney Information Network for Disease Research and Education

NCT03321604 | Terminated

• 1 other identifier: 2016P002671
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hemodialysis; Kidney; Dialysis; Kindred; Fabry; Massachusetts General Hospital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults receiving dialysis

You may qualify if:

• Adults between 18 and 65 with ESRD undergoing dialysis.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genzyme, a Sanofi Company: collaborator
• Scott and White Hospital & Clinic: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Related Links

• KINDRED Website

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, DNA

MeSH Terms

Conditions

Kidney Failure, Chronic; Fabry Disease; Rare Diseases; Kidney Diseases; Genetic Diseases, X-Linked

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 25, 2017
• Study Start: January 1, 2018
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)