Trial · NCT03177798
Mitochondria and Chronic Kidney Disease
NCT03177798, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2019-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mitochondria and Chronic Kidney Disease. Trials, record NCT03177798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03177798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mitochondria and Chronic Kidney Disease
- NCT number
- NCT03177798
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Hemodialysis-Induced Symptom, Mitochondrial Diseases
- Interventions
- Icatibant, Placebo
- First posted
- 2017-06-06
- Last updated
- 2019-10-29
- Results first posted
- 2019-10-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | 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 | Systolic Blood Pressure | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | Up to 2 hours after completion of drug infusion | seconds | MEAN | |
| SECONDARY | Systolic Blood Pressure | 30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysis | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | Icatibant | 60.59 | Standard Deviation 13.94 | seconds | |
| Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | Placebo | 62.66 | Standard Deviation 29.4 | seconds | |
| Systolic Blood Pressure | Icatibant | 30 minutes before hemodialysis | 123.36 | Standard Deviation 15.83 | mmHg |
| Systolic Blood Pressure | Placebo | 30 minutes before hemodialysis | 125.27 | Standard Deviation 25.04 | mmHg |
| Systolic Blood Pressure | Icatibant | during dialysis | 122.5454545 | Standard Deviation 16.87224725 | mmHg |
| Systolic Blood Pressure | Placebo | during dialysis | 122.18 | Standard Deviation 23.23 | mmHg |
| Systolic Blood Pressure | Icatibant | up to 1 hour after hemodialysis | 119.09 | Standard Deviation 19.06 | mmHg |
| Systolic Blood Pressure | Placebo | up to 1 hour after hemodialysis | 124.09 | Standard Deviation 19.90 | mmHg |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Icatibant Then Placebo | 5 | |
| Overall Study | STARTED | Placebo Then Icatibant | 6 | |
| Overall Study | Intervention 1 | Icatibant Then Placebo | 5 | |
| Overall Study | Intervention 1 | Placebo Then Icatibant | 6 | |
| Overall Study | Washout | Icatibant Then Placebo | 5 | |
| Overall Study | Washout | Placebo Then Icatibant | 6 | |
| Overall Study | Intervention 2 | Icatibant Then Placebo | 5 | |
| Overall Study | Intervention 2 | Placebo Then Icatibant | 6 | |
| Overall Study | COMPLETED | Icatibant Then Placebo | 5 | |
| Overall Study | COMPLETED | Placebo Then Icatibant | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Patient was admitted for possible kidney transplant | Renal and urinary disorders | Icatibant | 1 | 11 | 1 |
| other | Patient was admitted for possible kidney transplant | Renal and urinary disorders | Placebo | 0 | 11 | 0 |
| other | Arterious venous access thrombosis | Blood and lymphatic system disorders | Icatibant | 0 | 11 | 0 |
| other | Arterious venous access thrombosis | Blood and lymphatic system disorders | Placebo | 1 | 11 | 1 |
| serious | Hospitalization for cardiac catheterization | Cardiac disorders | Icatibant | 0 | 11 | |
| serious | Hospitalization for cardiac catheterization | Cardiac disorders | Placebo | 1 | 11 | |
| serious | Hypovolemia | Gastrointestinal disorders | Icatibant | 0 | 11 | |
| serious | Hypovolemia | Gastrointestinal disorders | Placebo | 1 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Icatibant | 0 | 11 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | Icatibant | 1 | 11 |
| Total, other adverse events | Placebo | 1 | 11 |
| Total, serious adverse events | Icatibant | 0 | 11 |
| Total, serious adverse events | Placebo | 2 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Icatibant vs Placebo: deaths from any cause | Trial comparisons |
| Icatibant vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03177798
GET https://conductscience.org/api/trials/v1/NCT03177798/registered