A Study to Evaluate Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies with Hypertension and Proteinuria

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-008702
    • Scottsdale/Phoenix, Arizona: 18-008702
    • Jacksonville, Florida: 18-008702
    NCT ID: NCT00369538, NCT03695380
    Sponsor Protocol Number: 3742

About this study

The purpose of this study is to quantify podocyturia during glomerular nephropathies by dosing podocyte microparticles ii) to study the relationship between podocyturia and other biologic markers such as proteinuria iii) to evaluate the effect of angiotensine 2 blockage on podocyturia.

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:

  • Hypertension (TAs > 130, TAd > 80mmHg or under antihypertensive treatment).
  • Glomerular nephropathy, proteinuria > 1 g/day, serum creatinin < 200 µmol/L.
  • Informed consent given.
  • No contraindication for ARB and hydrochlorothiazide.
  • Efficient contraception for women.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gerardo Colon-Otero, M.D.

Contact us for the latest status

Contact information:

Gerardo Colon-Otero M.D.

(904)953-8510

gcolonotero@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Gerardo Colon-Otero, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Gerardo Colon-Otero, M.D.

Open for enrollment

Contact information:

Gerardo Colon-Otero M.D.

(904)953-8510

gcolonotero@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20467299

Mayo Clinic Footer