Evaluating Childhood Cardiovascular Health Outcomes in NEPTUNE and CureGN

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-005971
    Sponsor Protocol Number: 15-005971

About this study

The purpose of this research study is to learn more about the risks to heart health in children and young adults with nephrotic syndrome. Nephrotic syndrome is a rare kidney condition that can affect children. They may be more likely to develop heart disease, high blood pressure and high cholesterol. We hope that the results of this study will help us to learn which tests should be used to determine which patients are most at risk for developing these illnesses.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  1. Participants age 6-21 years enrolled in either NEPTUNE or CureGN(The lower age limit was chosen based on ability to cooperate with study-related procedures.)

  2. Participants with a diagnosis of FSGS

  3. Participants with a diagnosis of MCNS with active disease defined as follows:

            a) steroid dependent- relapse during corticosteroid therapy or within 2 weeks of discontinuing corticosteroids

            b) frequently relapsing- ≥2 relapses in 6 months or ≥4 relapses in 12 months or

            c) steroid resistant - failure to induce remission with corticosteroids within 8 weeks

     4.   Informed consent from the parent or guardian and assent from a minor of ≥ 7 years

   Exclusion Criteria

  1. Participants with a diagnosis of IgA nephropathy, membranous nephropathy or other glomerular disease that is not FSGS or MCNS

  2. Participants on dialysis or who have a kidney transplant

  3. Participants with major co-morbid conditions such as cardiac disease, pulmonary disease, neurologic disease, diabetes mellitus or a genetic syndrome

  4. Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Cheryl Tran, M.D.

Open for enrollment

Contact information:

Julia Byrne

(507)538-0893

Byrne.Julia@mayo.edu