| Trial ID: | L0574 |
| Source ID: | NCT03177798
|
| Associated Drug: |
Icatibant
|
| Title: |
Mitochondria and Chronic Kidney Disease
|
| Acronym: |
MitoCKD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03177798/results
|
| Conditions: |
Hemodialysis-Induced Symptom|Mitochondrial Diseases
|
| Interventions: |
DRUG: Icatibant|DRUG: Placebo
|
| Outcome Measures: |
Primary: Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS), 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., Up to 2 hours after completion of drug infusion | Secondary: Systolic Blood Pressure, Blood pressure will be monitored every 15 minutes, before, during, and after hemodialysis., 30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysis
|
| Sponsor/Collaborators: |
Sponsor: Vanderbilt University Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2017-08-01
|
| Completion Date: |
2018-12-31
|
| Results First Posted: |
2019-10-29
|
| Last Update Posted: |
2019-10-29
|
| Locations: |
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03177798
|
