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Proteomics of Primary Hyperoxaluria Type 1

NCT03067142 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2019-06-12

No results posted yet for this study

Summary

The purpose of this study is to identify unique urine protein markers of Primary Hyperoxaluria type 1 (PH1) compared to healthy controls. Urine protein markers can be identified by "proteomic" analyses in which proteins are processed in a lab to break them down into smaller building blocks. Using analytical chemistry techniques and specialized equipment many proteins can be identified and measured. Most proteins are found in healthy living cells while subtle changes in these proteins or the presence of different markers reflect abnormal processes and patterns of disease. When identified in disease, protein biomarkers can help to determine if a disease responds to new types of therapies. In this study, changes in urine proteomic patterns over time, their association with change in estimated (calculated) kidney filtering function, and the relative risk for progression of PH1 will be determined. Additionally, as part of the study, the investigators will measure urinary proteins and peptides that are markers of kidney tissue protection (for healthy healing of the kidneys from ongoing damage from high urine oxalate levels, oxalate crystals and stones) to establish if and when these markers are prospectively decreased in PH1 urine. Longitudinal studies of urine "proteomics" may assist in identifying the mechanisms behind PH1-related progression of kidney failure and might contribute important information towards future identification and development of effective therapies to slow or prevent kidney failure in PH1.

Conditions

  • Primary Hyperoxaluria Type 1

Interventions

OTHER

Observational

Not an interventional study. Analyses of previously collected urine specimens and data on estimated kidney filtering function.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Craig B Langman, MD · Ann & Robert H Lurie hildren's Hospital of Chicago, Division of Kidney Diseases

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2019-03-30
Completion
2019-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067142 on ClinicalTrials.gov