A Registry and Biospecimen Collection to Advance the Diagnosis and Care of Patients with Glomerular Diseases

Overview

About this study

Aim 1 (Epidemiology). To describe the disease trajectory under current clinical care; to estimate event rates for clinically meaningful outcomes; to identify patient characteristics (demographic, clinical, laboratory, environmental) associated with glomerular disease and non-renal complications of disease; to identify clinical predictors of short- and long-term outcomes, including therapeutic response; and to evaluate intermediate outcomes, such as proteinuria, as potential surrogates for longer-term outcomes.

Aim 2 (Biomarkers). To identify and characterize clinical, histological, molecular, and genetic biomarkers that are linked to glomerular disease, disease outcomes, or that might be used to improve disease classification; to identify and characterize biomarkers that may be employed in clinical practice or clinical trials to predict disease trajectory, disease activity, or response to therapy.

Aim 3 (Genetics). To understand the genetic architecture of the four glomerulopathies, including studies of germline sequence variation, somatic mutations, epigenetic changes, and transcriptomic profile, and their impact on disease presentation and clinical outcome; study gene-gene and gene-environment interactions that contribute to the development of the four glomerulopathies; and devise systems genetics approach to clarify pathogenesis.

Aim 4 (PROs). To identify Patient Reported Outcomes (PROs, e.g., symptom burden, physical function, quality of life) associated with primary glomerular diseases; to validate disease-specific instrument(s) to assess the impact of disease and its therapy on patients; and to test the associations of PROs with disease progression.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, per specified pathology definitions.
  • First diagnostic kidney biopsy within 5 years of study enrollment.
  • Access to first kidney biopsy report and/or slides.
  • All ages.
  • Willing to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site.
  • Informed consent and, where age appropriate, informed assent.

 Exclusion Criteria

  • ESKD, defined as chronic dialysis or kidney transplant.
  • Institutionalized.
  • Solid organ or bone marrow transplant recipient at time of first kidney biopsy.
  • Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
    • Diabetes mellitus;
    • Histopathologic findings of diabetic glomerulosclerosis;
    • Systemic lupus erythematosus;
    • HIV infection;
    • Active malignancy, except for non-melanoma skin cancer;
    • Active Hepatitis B or C infection, defined as positive viral load.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Open for enrollment

Contact information:

Vladimir Chernitskiy CCRP

(507) 255-0231

MNCG@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20502816

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