Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure

End Stage Renal Disease Clinical Trial

— FSGS  

Official title:

Molecular and Genetic Analysis of Inherited Kidney Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02194582
• Other study ID #: 2009P000430
• Secondary ID: 5R01DK054931-18
• Status: Active, not recruiting
• Start date: June 1996
• Est. completion date: January 2035

Study information

• Verified date: March 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators are trying to learn more about the cause of kidney diseases such as Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic syndrome by studying genetics. The investigators are interested in discovering which genes play a role in causing a predisposition to FSGS/NS. The investigators also want to learn why FSGS/NS can run in families. Participation in our study involves a saliva sample and a urine sample that you can give from home. There is no cost to participate. All information is kept private and confidential. The investigators also like to include healthy volunteers (parents, spouses) if interested/available but of course this is completely optional.

Description:

The investigators welcome anyone (with or without a family history) with unexplained, non syndromic FSGS, nephrotic syndrome, or proteinuria to join the study. Participation involves a saliva (or blood if it is preferable) sample and urine sample (if applicable). There is no cost to participate and the study can be done from home in most cases.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2050
• Est. completion date: January 2035
• Est. primary completion date: January 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects with FSGS (focal segmental glomerulosclerosis)
• Subjects with NS (nephrotic syndrome)
• Subjects with unexplained kidney failure (have had a transplant or on dialysis)
• Subjects with unexplained proteinuria
• Family members of a person with FSGS, NS, kidney failure, or unexplained protein in their urine
• Healthy volunteers

Exclusion Criteria:

• Patients whose kidney disease is already explained by another syndrome such as (Branchio Oto Renal Syndrome or Alports syndrome)
• Patients who already know the genetic cause of their kidney disease

Related Conditions & MeSH terms

• End Stage Renal Disease
• Focal Segmental Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Nephrosis
• Nephrotic Syndrome
• Proteinuria
• Renal Insufficiency
• Syndrome
• Unexplained Proteinuria

Locations

Country	Name	City	State
United States	BIDMC	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the genetic causes of FSGS, NS, and idiopathic proteinuria/ESRD in patients and families	This is an ongoing study for research purposes only.	2035

External Links

•   BIDMC - Pollak Lab Website