Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.
| Group | Value (mL/min) | Spread |
|---|---|---|
| Bendavia | 6.3 | 12.14 |
| Placebo | 12.0 | 23.84 |
Trial · Interventional
TerminatedPhase 1/2Results postedRegistry dataShort name EVOLVE
This trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).
Experimental
Bendavia
Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.
Placebo comparator
Placebo
Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.
Outcomes the sponsor listed as primary.
Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.
Time frame · Baseline (pre-PTRA) and 8 weeks post-PTRA
Change in mean glomerular filtration rate (GFR), as measured by iothalamate clearance, from baseline (pre-percutaneous renal artery angioplasty, or pre-PTRA) and 8 weeks post-PTRA..
Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Time frame · Baseline (pre-PTRA) and 8 weeks post-PTRA
Change in mean glomerular flow rate as measured using Multi-Detector Computed Tomography (MDCT) at baseline (pre-PTRA) and 8 weeks post-PTRA, stented quantifiable scanned kidneys.
Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Time frame · Baseline (pre-PTRA) and 8 weeks post-PTRA
Change in mean regional perfusion as measured by Multi-Detector Computed Tomography (MDCT) Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys.
Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA
Time frame · Baseline (pre-PTRA) and 8 weeks post-PTRA
Change in mean renal blood flow (ml/minute) as measured using Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys
Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.
Time frame · Baseline (Pre-PTRA) and 8 (+4) weeks post-PTRA
Change in mean renal volume as measured by Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA.
Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA
Time frame · Baseline (Pre-PTRA) , 27 hours post-PTRA and 8 weeks post-PTRA
Mean change in renal oxygenation, axial aspect, in stented kidneys between baseline (pre-PTRA), and 27 hours post-PTRA and 8 weeks post-PTRA as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging.
Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA
Time frame · 27H post PTRA and 8 weeks Post PTRA
Mean change in renal oxygenation, coronal aspect, in stented kidneys between baseline (pre-PTRA) and 27 hours post-PTRA or 8 weeks post-PTRA, as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging, with and without Bendavia
Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA
Time frame · Pre-PTRA and 27 hours post-PTRA and 8 weeks post-PTRA
Mean Change in Diastolic Blood Pressure
Time frame · Pre-PTRA, immediately post-PTRA, 27 hours post-PTRA and 8 weeks post-PTRA
Mean Change in Diastolic Blood Pressure (DBP) values (mmHg) from baseline (pre-PTRA), immediately post-PTRA, 27 hours and 8 weeks post-PTRA, with and without Bendavia.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mL/min) | Spread |
|---|---|---|
| Bendavia | 6.3 | 12.14 |
| Placebo | 12.0 | 23.84 |
| Group | Value (mL/min) | Spread |
|---|---|---|
| Bendavia | 0.238 | 0.2557 |
| Placebo | 0.010 | 0.0552 |
| Group | Value (mL/min) | Spread |
|---|---|---|
| Bendavia | 1.266 | 0.9341 |
| Placebo | -0.816 | 0.6614 |
| Group | Value (mL/min) | Spread |
|---|---|---|
| Bendavia | 85.056 | 63.2943 |
| Placebo | -28.406 | 54.8919 |
| Group | Value (mL) | Spread |
|---|---|---|
| Bendavia | 1.270 | 12.8218 |
| Placebo | 4.708 | 13.7198 |
| Group | Value (s^-1) | Spread |
|---|---|---|
| Bendavia | 13.440 | 34.6825 |
| Placebo | 16.708 | 19.4980 |
| Group | Value (s^-1) | Spread |
|---|---|---|
| Bendavia | 20.314 | 33.3525 |
| Placebo | 9.083 | 17.3368 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Bendavia | -2.9 | 14.78 |
| Placebo | -3.8 | 15.69 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| BendaviaBendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours. | 0 / 7 | 1 / 7 | 2 / 7 |
| PlaceboPlacebo (no active drug), intravenous infusion, for a maximum duration of 4 hours. | 0 / 9 | 1 / 9 | 5 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2017
Saad et al. 2017Circulation. Cardiovascular interventionscited by 95
PMID 28916603PMC5659347DOI 10.1161/circinterventions.117.005487PUB-28916603
Who could join, as posted.
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