Hypoxia and Inflammatory Injury in Human Renovascular Hypertension

Overview

  • Study type

    Interventional
  • Study phase

    I
  • 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: 14-002799
    NCT ID: NCT02266394
    Sponsor Protocol Number: 14-002799

About this study

Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells" or MSC. Mesenchymal stem cells (MSC) are grown from a person's own fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney. This study is also being done to determine if the MSC infusion prior to percutaneous transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney blood flow and restoration of kidney function, as well as to assess the relationship between MSC dose and measures of kidney function.

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:

  • Creatinine <2.2 mg/dL for Caucasian males, <2.0 Caucasian females,< 2.4 African-American males, <2.1 mg/dL African-American females
  • Hypertension (Systolic BP>155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) prior to study.
  • Angiotensin Converting Enzyme (ACE inhibitor) or Angiotensin Receptor Blocker (ARB) therapy maintained or initiated at usual recommended daily dose (equivalent: 40 mg lisinopril) .

Exclusion Criteria:

  • Diabetes requiring insulin or oral hypoglycemic medications (see text)
  • Known allergy to furosemide or iodinated intravenous contrast
  • Pregnancy
  • Recent Cardiovascular event: Myocardial infarction, stroke, congestive heart failure within 3 months
  • Cardiac ejection fraction less than 30%
  • Evidence of hepatitis B or C, or HIV infection
  • requirement for potentially nephrotoxic drugs, e.g. non-steroidal anti-inflammatory drugs
  • Uncontrolled hypertension: SBP >180 mm Hg, despite antihypertensive therapy
  • Kidney transplant
  • Pacemaker, implantable defibrillator or other contraindication to Magnetic resonance imaging
  • Inability to comply with breath-hold for 30 seconds
  • History of deep venous thrombosis within 3 months of enrollment
  • contraindications to renal biopsy including artificial valve requiring continuous anticoagulation

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Textor, M.D.

Open for enrollment

Contact information:

Beverly Tietje

(507)255-0401

Tietje.Beverly@mayo.edu