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NCT03177798·Phase 2·INTERVENTIONAL

Mitochondria and Chronic Kidney Disease

IcatibantOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

11

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Icatibant

Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, The investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.

DRUG

Placebo

Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.

Timeline

From registration to results.

  1. First posted

    Jun 6, 2017

  2. Study start

    Aug 1, 2017

  3. Primary completion

    Jun 30, 2018

  4. Study completion

    Dec 31, 2018

  5. Results posted

    Oct 29, 2019

  6. Registry updated

    Oct 29, 2019

Outcomes

What the study measures.

Primary outcomes

Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)

Time frame · Up to 2 hours after completion of drug infusion

Mitochondria function will be evaluated using 31P-MRS, which evaluates the concentration of phospho-creatine (PCr) and other phosphate-energy carrier molecules. After basal measurements, subjects will be asked to perform 90 seconds of knee extension followed by 4 minutes of rest. The exercise/rest cycle will be repeated 3 times. Magnetic resonance spectra will be used to calculate concentrations of inorganic phosphate (Pi), PCr, and adenosine triphosphate (ATP). The time constant tau of PCr recovery (time to achieve 66.3% maximal concentration during recovery) will be used to determine mitochondrial function.

Secondary outcomes

Systolic Blood Pressure

Time frame · 30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysis

Blood pressure will be monitored every 15 minutes, before, during, and after hemodialysis.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
78 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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