Mitochondria and Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 78 |
| Updated: | 4/6/2019 |
| Start Date: | August 1, 2017 |
| End Date: | December 31, 2018 |
Mitochondrial Dysfunction in Chronic Kidney Disease
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.
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.
Inclusion Criteria:
- Adult patients who have been on maintenance hemodialysis for at least 6 months
Exclusion Criteria:
- 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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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