Trial Outcomes & Findings for Mitochondria and Chronic Kidney Disease (NCT NCT03177798)
NCT ID: NCT03177798
Last Updated: 2019-10-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 2 hours after completion of drug infusion
Results posted on
2019-10-29
Participant Flow
Cross-over design, eleven individuals receive both treatments, Icatibant and placbo
Participant milestones
| Measure |
Icatibant Then Placebo
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Washout, then
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours)
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
Placebo Then Icatibant
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Washout, then
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
Intervention 1
|
5
|
6
|
|
Overall Study
Washout
|
5
|
6
|
|
Overall Study
Intervention 2
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mitochondria and Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Icatibant Then Placebo
n=5 Participants
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours)
Washout, then
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours)
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
Placebo Then Icatibant
n=6 Participants
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Washout, then
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 11.08 • n=99 Participants
|
44.3 years
STANDARD_DEVIATION 11.32 • n=107 Participants
|
44.73 years
STANDARD_DEVIATION 10.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 2 hours after completion of drug infusionMitochondria 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.
Outcome measures
| Measure |
Icatibant
n=11 Participants
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours)
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.
|
Placebo
n=11 Participants
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours)
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.
|
|---|---|---|
|
Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
|
60.59 seconds
Standard Deviation 13.94
|
62.66 seconds
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: 30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysisBlood pressure will be monitored every 15 minutes, before, during, and after hemodialysis.
Outcome measures
| Measure |
Icatibant
n=11 Participants
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours)
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.
|
Placebo
n=11 Participants
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 30 minutes prior to the initiation of dialysis and continue through hemodialysis (4 hours)
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.
|
|---|---|---|
|
Systolic Blood Pressure
30 minutes before hemodialysis
|
123.36 mmHg
Standard Deviation 15.83
|
125.27 mmHg
Standard Deviation 25.04
|
|
Systolic Blood Pressure
during dialysis
|
122.5454545 mmHg
Standard Deviation 16.87224725
|
122.18 mmHg
Standard Deviation 23.23
|
|
Systolic Blood Pressure
up to 1 hour after hemodialysis
|
119.09 mmHg
Standard Deviation 19.06
|
124.09 mmHg
Standard Deviation 19.90
|
Adverse Events
Icatibant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Icatibant
n=11 participants at risk
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
Placebo
n=11 participants at risk
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
|---|---|---|
|
Cardiac disorders
Hospitalization for cardiac catheterization
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • 6 months
|
|
Gastrointestinal disorders
Hypovolemia
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • 6 months
|
Other adverse events
| Measure |
Icatibant
n=11 participants at risk
Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
Placebo
n=11 participants at risk
Placebo will be intravenously infused at the same rate of Icatibant (50 ug/kg/h) for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).
Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
|
|---|---|---|
|
Renal and urinary disorders
Patient was admitted for possible kidney transplant
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Blood and lymphatic system disorders
Arterious venous access thrombosis
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
Additional Information
Dr. Jorge L. Gamboa
Vanderbilt University Medical Center
Phone: 615-343-4176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place