Chronic Kidney Disease Clinical Trial
Official title:
Cardiomyopathy in Steroid-resistant Nephrotic Syndrome: Impact of Focal Segmental Glomerulosclerosis
Verified date | June 2013 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The objective of this study is as follows:
- Perform genetic analysis to define the prevalence of each of the known gene mutations
in an unselected cohort of patients with focal segmental glomerulosclerosis (FSGS)
- Perform a comprehensive assessment of cardiovascular status to determine the incidence
of any cardiac abnormalities in patients with FSGS
- Determine if patients with mutations in specific proteins are more likely to have
cardiovascular abnormalities
- Initiate long-term follow up in all patients to determine whether cardiac prognosis is
related to any specific genetic abnormality
Status | Terminated |
Enrollment | 4 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 21 Years |
Eligibility |
Inclusion Criteria: - Age 6 months - 21 years - SRNS, defined as failure to achieve remission in proteinuria after 4-6 weeks of daily steroid therapy in accord with ISKDC guidelines - GFR > 30 ml/min/1.73 m^2 - Renal disease diagnosed based on kidney biopsy Exclusion Criteria: - Secondary FSGS - Prior renal transplantation - Congenital extra-renal abnormalities - Significant structural cardiac abnormalities - pulmonary, hematologic, malignancy, or immune-related disease - inability to maintain adequate follow-up |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Schneider Children's Hospital | New Hyde Park | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence or Absence of any of the podocin gene mutations | Presence or Absence of any of the podocin gene mutations podocin gene (NPHS2) CD2-associated protein (CD2AP) actinin-4 (ACTN4) Nephrotic syndrome steroid-resistant gene (SRN1) Wilms Tumor 1(WT1) Transient receptor potential cation channel, subfamily C, member 6 (TRPC6) Phospholipase C-E1 (PLCE-1) |
baseline | No |
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