Nephrotic Syndrome Study Network

Study ID
STU 112012-082

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Tammy Lightfoot
214-645-8265
tammy.lightfoot@utsouthwestern.edu

Principal Investigator
Kamalanathan Sambandam

Summary

This is not a treatment study. This is a multi-center incident, observational cohort panel: Prospective, un-blinded, standardized evaluation of clinical outcomes. 250 FSGS/MCD, 200 Mn and other Glomerulopathies (oG) Cohort subjects enrolled at a constant rate over 30 months with a minimum follow-up of 30 months. There will be 14 academic clinical centers in united States and 1 center in Canada will participate in this study.

The sampling method is a consecutive sample of all eligible and consenting patients. a [Quote]recruit-to-replace[Quote] strategy to preserve sample size of 250/200 subjects at the end of recruitment.

This study involves a screening and baseline visit and additional followup visits after the standard of care kidney biopsy. Participants will be screened with a medical history and physical examination, as well as blood and urine samples and collection of fingernail clippings. Participants will also complete questionnaires about their history of kidney problems. During the kidney biopsy, performed at the niH Clinical Center, researchers will take an additional tissue sample for research. Participants will return for followup visits at niH every 4 months in the first year, and every 6 months in the second through fifth years after the biopsy. additional blood and urine samples will be collected at each visit, and fingernail clippings will also be collected annually by the study researchers. Treatment for kidney disease will not be provided as part of this protocol and instead will generally be provided by the patient's own physician.

The primary outcome variables are: 1)event rate change in urinary proteinuria excretion(remission, partials remission and non-remission) 2) Rate of change in renal function: 25mls/min/1.73m2 reduction in follow up estimated GFR compared to baseline GFR, 50% decline in follow up estimated GFR compared to baseline measurement and end stage renal disease.

The secondary outcome variables for the nePTune main study cohort are: 1)Patient reproted outcomes will be assessed using Quality of Life SF-36, PedsQL and Patient Reported outcome Measurement information System (PRoMiS) questionnaires. 2) new onset Diabetes. 3) Malignancies of the skin, hematopoietic, or solid organ cancers after enrollment. 4) infectious, seroius and systemic infections of the skin or subcutaneous tissue, vascular system, peritoneum, or vital organs requiring antibiotics ( iV or oral) for [Greater Than]/[?]72 hours. 5) Thromboembolic events: renal and deep vein thrombosis, pulmonary embolus and embolic cerebrovascular accident.60 Hospitalization hours or eR/ observation unit visit [Greater Than]/[?] 24 . 7) acute Kidney injury 8) Death.

Participant Eligibility


* INCLUSION CRITERIA
Inclusion Criteria for the FSGS/MCD Cohort


* A new diagnosis of FSGS or MCD according to characteristic light, electron (EM), and immunofluorescence microscopy (IM), with presence of at least five glomeruli per biopsy available for analysis. Biopsy slides will be reviewed and diagnosis confirmed by 2 study pathologists according to standardized criteria developed by the pathology committee;

* Documented urinary protein excretion greater than or equal to 500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.

Inclusion criteria for the MN Cohort


* A new diagnosis of MN according to characteristic light, electron (EM), and immunofluorescence microscopy (IM), with presence of diagnostic changes in at least one glomerulus per biopsy. Biopsy slides will be reviewed and diagnosis confirmed by 2 study pathologists according to standardized criteria developed by the pathology committee

* Documented urinary protein excretion greater than or equal to 500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.

Inclusion criteria for the OG Cohort


* A new diagnosis of glomerulopathy according to characteristic light, electron (EM), and immunofluorescence microscopy (IM), with presence of diagnostic changes in at least one glomerulus per biopsy. Biopsy slides will be reviewed and diagnosis confirmed by 2 study pathologists according to standardized criteria developed by the pathology committee;

* Documented urinary protein excretion greater than or equal to 500 mg/24 hours or spot protein:creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit