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Trial record 13 of 23 for:    ICATIBANT

Mitochondria and Chronic Kidney Disease (MitoCKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03177798
Recruitment Status : Completed
First Posted : June 6, 2017
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jorge Gamboa, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Hemodialysis-Induced Symptom
Mitochondrial Diseases
Interventions Drug: Icatibant
Drug: Placebo
Enrollment 11
Recruitment Details Cross-over design, eleven individuals receive both treatments, Icatibant and placbo
Pre-assignment Details  
Arm/Group Title Icatibant Then Placebo Placebo Then Icatibant
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 5 6
Intervention 1 5 6
Washout 5 6
Intervention 2 5 6
Completed 5 6
Not Completed 0 0
Arm/Group Title Icatibant Then Placebo Placebo Then Icatibant Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
Patients on hemodialysis three times a week for at least six months
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 11 participants
45.2  (11.08) 44.3  (11.32) 44.73  (10.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
2
  40.0%
1
  16.7%
3
  27.3%
Male
3
  60.0%
5
  83.3%
8
  72.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  80.0%
4
  66.7%
8
  72.7%
White
1
  20.0%
1
  16.7%
2
  18.2%
More than one race
0
   0.0%
1
  16.7%
1
   9.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5 6 11
1.Primary Outcome
Title Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
Hide Description 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.
Time Frame Up to 2 hours after completion of drug infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: seconds
60.59  (13.94) 62.66  (29.4)
2.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Blood pressure will be monitored every 15 minutes, before, during, and after hemodialysis.
Time Frame 30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description:
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). Blood pressure was monitored before, during, and up to 1 hour after the end of the hemodialysis procedure.
Placebo was 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). Blood pressure was monitored before, during, and up to 1 hour after the end of the hemodialysis procedure.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: mmHg
30 minutes before hemodialysis 123.36  (15.83) 125.27  (25.04)
during dialysis 122.5454545  (16.87224725) 122.18  (23.23)
up to 1 hour after hemodialysis 119.09  (19.06) 124.09  (19.90)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Icatibant Placebo
Hide Arm/Group Description

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 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.

All-Cause Mortality
Icatibant Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Icatibant Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      2/11 (18.18%)    
Cardiac disorders     
Hospitalization for cardiac catheterization  [1]  0/11 (0.00%)  1/11 (9.09%) 
Gastrointestinal disorders     
Hypovolemia  [2]  0/11 (0.00%)  1/11 (9.09%) 
Indicates events were collected by systematic assessment
[1]
Unrelated to the study intervention. Patient require cardiac stent placement due to coronary artery disease
[2]
Unrelated to the study. Patients was hospitalized due to hypovolemia secondary to gastrointestinal disorders
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Icatibant Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/11 (9.09%)    
Blood and lymphatic system disorders     
Arterious venous access thrombosis * [1]  0/11 (0.00%)  0 1/11 (9.09%)  1
Renal and urinary disorders     
Patient was admitted for possible kidney transplant  [2]  1/11 (9.09%)  1 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Unrelated to the the study. Patient had thrombosis of the AV access that requires revascularization.
Indicates events were collected by systematic assessment
[2]
Patient did not match and was not eligible for kidney transplant
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jorge L. Gamboa
Organization: Vanderbilt University Medical Center
Phone: 615-343-4176
EMail: jorge.gamboa@vumc.org
Layout table for additonal information
Responsible Party: Jorge Gamboa, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03177798     History of Changes
Other Study ID Numbers: 131602
First Submitted: May 8, 2017
First Posted: June 6, 2017
Results First Submitted: August 20, 2019
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019