- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194582
Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure (FSGS)
March 9, 2023 updated by: Martin R. Pollak, Beth Israel Deaconess Medical Center
Molecular and Genetic Analysis of Inherited Kidney Dysfunction
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.
Study Overview
Status
Active, not recruiting
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
2050
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- BIDMC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We are recruiting subjects who have kidney disease, family members of a person with kidney disease, and healthy controls.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify the genetic causes of FSGS, NS, and idiopathic proteinuria/ESRD in patients and families
Time Frame: 2035
|
This is an ongoing study for research purposes only.
|
2035
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martin R Pollak, MD, Beth Israel Deaconess Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 1996
Primary Completion (Anticipated)
January 1, 2035
Study Completion (Anticipated)
January 1, 2035
Study Registration Dates
First Submitted
July 16, 2014
First Submitted That Met QC Criteria
July 17, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Estimate)
March 10, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009P000430
- 5R01DK054931-18 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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