Mitochondria and Chronic Kidney Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Hemodialysis-Induced Symptom, Mitochondrial Diseases

In brief

The overarching goal of this study is to determine the role of chronic kidney disease and the activation of the kallikrein-kinin system during hemodialysis on the development of mitochondrial dysfunction; the investigators will measure mitochondrial function using the gold standard method, 31-phosphorus magnetic resonance spectroscopy. The investigators will test the hypothesis that endogenous bradykinin promotes mitochondrial dysfunction in patients undergoing hemodialysis. The investigators will first perform a randomized, placebo-controlled, double-blind, cross-over study measuring the effect of Icatibant (HOE-140), a bradykinin B2 receptor blocker, on mitochondrial function.

Key facts

Study ID

NCT03177798

Run by

Vanderbilt University Medical Center

People needed

11

Starts

2017-08-01

Expected to finish

2018-12-31

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients who have been on maintenance hemodialysis for at least 6 months

You may not qualify if…

• History of functional transplant less than 6 months prior to study
• Use of immunosuppressive drugs within 1 month prior to study
• History of active connective tissue disease
• History of acute infectious disease within one month prior to study
• AIDS (HIV seropositivity is not an exclusion criteria)
• History of myocardial infarction or cerebrovascular event within 3 months
• Advanced liver disease
• Gastrointestinal dysfunction requiring parental nutrition
• Active malignancy excluding basal cell carcinoma of the skin
• Ejection fraction less than 30%
• Anticipated live donor kidney transplant
• Pregnancy, breast-feeding or child-bearing potential
• History of poor adherence to hemodialysis or medical regimen
• Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies that are contraindicated in magnetic resonance imaging.
• Inability to provide consent

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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