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Trial record 35 of 49 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure (FSGS)

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ClinicalTrials.gov Identifier: NCT02194582
Recruitment Status : Recruiting
First Posted : July 18, 2014
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
United States Department of Defense
Information provided by (Responsible Party):
Martin R. Pollak, Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease
Focal Segmental Glomerulosclerosis Nephrotic Syndrome End Stage Renal Disease Kidney Failure Unexplained Proteinuria

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.

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Study Type : Observational
Estimated Enrollment : 2050 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Molecular and Genetic Analysis of Inherited Kidney Dysfunction
Actual Study Start Date : June 1996
Estimated Primary Completion Date : January 2035
Estimated Study Completion Date : January 2035





Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Usually saliva In some cases, a blood sample may be obtained In some cases, a urine sample may be requested


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194582


Contacts
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Contact: Andrea L Knob, MS aknob@bidmc.harvard.edu

Locations
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United States, Massachusetts
BIDMC Recruiting
Boston, Massachusetts, United States, 02215
Contact: Andrea L Knob, MS    617-667-0467    aknob@bidmc.harvard.edu   
Principal Investigator: Martin R Pollak, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
United States Department of Defense
Investigators
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Principal Investigator: Martin R Pollak, MD Beth Israel Deaconess Medical Center

Additional Information:
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Responsible Party: Martin R. Pollak, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02194582     History of Changes
Other Study ID Numbers: 2009P000430
5R01DK054931-18 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Keywords provided by Martin R. Pollak, Beth Israel Deaconess Medical Center:
FSGS
NS
Kidney disease
Kidney failure
Renal disease
nephrotic syndrome
focal segmental glomerulosclerosis
familial kidney disease
minimal change disease
proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Disease
Urologic Diseases
Renal Insufficiency, Chronic
Urination Disorders
Proteinuria
Nephrotic Syndrome
Nephrosis
Glomerulosclerosis, Focal Segmental
Syndrome
Pathologic Processes
Urological Manifestations
Signs and Symptoms
Glomerulonephritis
Nephritis