Multiomic Urine, Serum and Tissue Assessment of Nephrosis and Glomerulonephritis

M
Myda Khalid

Primary Investigator

Enrolling By Invitation
1 years - 21 years
All
Phase N/A
400 participants needed
1 Location

Brief description of study

What is the purpose of this study?

There has been rapid new drug development in rare kidney diseases but current trials are in individuals ages 18 or older only. There is an urgent need to include children in the trials given the significant burden of kidney disease in the pediatric population. Identification of subgroups within affected children benefitting the most from individualized new therapies is paramount and will pave the way for high impact clinical trials in children. Biomarkers are a method of identifying subgroups within patients. We propose a single center, prospective observational study for collecting serum, urine and kidney tissue along with pertinent clinical data in children presenting to Riley Hospital for Children at Indiana University Health, age 1 yr to 21yrs with kidney disease for new biomarker discovery.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be identified from Nephrology Clinic, Inpatient admissions, ER, general pediatric clinic and those undergoing kidney biopsies at Riley hospital and IU North hospital. Potential subjects will be identified by looking at the schedule to determine potential inclusion in the study or referred by nephrologists. The controls with no kidney disease will be recruited from other pediatric clinics and pediatric surgery. The follow up visits will occur at FINN clinic which will be held at CCRC at Riley hospital.

Detailed description of study

What will happen during the study?

The purpose of this study is to create a research resource for etiological studies of congenital anomalies of the kidney and urinary tract.  Blood will be drawn at routine clinic visits (and left over blood from lab draw may be used) visits 5-7 ml if the subject is an infant or child.  Urine will also be collected.  

OBJECTIVES Aim1 a: Profile urine and serum omic (e.g., metabolomic, proteomic and lipidomic, transcriptomic, and/or cell subtype profiles in the serum and urine of children presenting with glomerulonephritis, nephrotic syndrome (nephrosis) and hemolytic uremic syndrome who are treatment naive

Aim 1b: Trend the changes in patterns omic and cell type expression profiele profiles in the serum and urine of children as they undergo treatment till disease remission or duration of follow up clinically indicated.

Aim 1c: Correlate the omic and cell type profiles in serum and urine with clinical parameters, disease flare and disease remission for duration of follow up

Aim 2: Spatial omics for kidney biopsy tissue and its correlation with metabolomic, proteomic and lipidomic profiles in affected children

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nephrotic syndrome, Nephritis, Hemolytic uremic, Riley
  • Age: 1 years - 21 years
  • Gender: All

Inclusion:

  • Incident and prevalent children ages 1 to 21 yrs with new onset nephrotic syndrome, nephritis, hemolytic uremic syndrome 
    MCD
    FSGS
    IgAN
    IgAVN
    C3GN
    HUS

Exclusion: 

  • Children in whom nephritis is secondary to another disease including, known genetic condition resulting in nephrotic syndrome, known pregnancy, HIV, Hep B, Hep C, HIV, malignancy, medication exposure.

Updated on 15 May 2025. Study ID: PNEPH-IIR-MUSTANG, 26100
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only