Phase 2 N=11 Randomized Quadruple-blind Prevention

Mitochondria and Chronic Kidney Disease

Hemodialysis-Induced Symptom · Mitochondrial Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03177798 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Oct 2019

Primary outcome: Primary: Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) — 60.59; 62.66 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Icatibant (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)	60.59; 62.66	—
SECONDARY Systolic Blood Pressure	123.36; 125.27; 122.5454545; 122.18; 119.09; 124.09	—

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT03177798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.