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Study · Randomized controlled trial · n = 14 · 2017

5 results

Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) During Stent Revascularization in Patients With Atherosclerotic Renal Artery Stenosis.

Saad A, Herrmann SMS, Eirin A, Ferguson CM, Glockner JF, Bjarnason H, McKusick MA, Misra S, Lerman LO, Textor SC

Circulation. Cardiovascular interventions1 Sept 2017Cited by 95 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with atherosclerotic renal artery stenosis, fractional hypoxia of the stenotic kidney rose with placebo but not with elamipretide 24 hours after angiography and stenting.

    In plain wordsIn people with narrowed kidney arteries, kidney oxygen shortage rose after stenting with placebo but not with elamipretide.

    Outcome
    DecreaseFractional hypoxia 24 hours after angiography and stenting
    Study

    n = 14

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    0.05 mg/kg per hour · intravenous · before and during PTRAAs given in this study (human).

    Measurements

    Change in fractional hypoxia
    47%
    placebo
    Change in fractional hypoxia
    −6%
    elamipretide

    Source sentences

    Summary
    Blood oxygen level-dependent imaging demonstrated increased fractional hypoxia 24 hours after angiography and stenting in placebo (+47%) versus elamipretide (-6%).
    2 context sentences
    Summary · context
    Inpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA.
    Summary · context
    Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with atherosclerotic renal artery stenosis, the changes in fractional hypoxia had returned to baseline 3 months after the procedure.

    In plain wordsIn people with narrowed kidney arteries, the early changes in kidney oxygen shortage were back at baseline 3 months later.

    Outcome
    No significant changeFractional hypoxia 3 months after PTRA
    Study

    n = 14

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    0.05 mg/kg per hour · intravenous · before and during PTRAAs given in this study (human).

    Source sentences

    Summary
    These were reverted to baseline 3 months later.
    3 context sentences
    Summary · context
    Blood oxygen level-dependent imaging demonstrated increased fractional hypoxia 24 hours after angiography and stenting in placebo (+47%) versus elamipretide (-6%).
    Summary · context
    Inpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA.
    Summary · context
    Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with atherosclerotic renal artery stenosis, systolic blood pressure decreased over 3 months more in the elamipretide group than in the placebo group.

    In plain wordsIn people with narrowed kidney arteries, systolic blood pressure fell over 3 months more with elamipretide than with placebo.

    Outcome
    DecreaseSystolic blood pressure over 3 months
    Study

    n = 14

    Comparator
    Placebo
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    0.05 mg/kg per hour · intravenous · before and during PTRAAs given in this study (human).

    Source sentences

    Summary
    Over 3 months, systolic blood pressure decreased, and estimated glomerular filtration rate increased (P=0.003) more in the elamipretide group than in the placebo group (P=0.11).
    2 context sentences
    Summary · context
    Inpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA.
    Summary · context
    Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with atherosclerotic renal artery stenosis, estimated glomerular filtration rate increased more over 3 months in the elamipretide group (P=0.003) than in the placebo group (P=0.11).

    In plain wordsIn people with narrowed kidney arteries, kidney filtering rate rose more over 3 months with elamipretide than with placebo.

    Outcome
    IncreaseEstimated glomerular filtration rate over 3 months
    Study

    n = 14

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    0.05 mg/kg per hour · intravenous · before and during PTRAAs given in this study (human).

    Source sentences

    Summary
    Over 3 months, systolic blood pressure decreased, and estimated glomerular filtration rate increased (P=0.003) more in the elamipretide group than in the placebo group (P=0.11).
    2 context sentences
    Summary · context
    Inpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA.
    Summary · context
    Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with atherosclerotic renal artery stenosis, stenotic kidney renal blood flow rose 3 months after PTRA in the elamipretide group only.

    In plain wordsIn people with narrowed kidney arteries, blood flow to the narrowed kidney rose after 3 months in the elamipretide group only.

    Outcome
    IncreaseStenotic kidney renal blood flow at 3 months
    Study

    n = 6

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    0.05 mg/kg per hour · intravenous · before and during PTRAAs given in this study (human).

    Measurements

    Stenotic kidney renal blood flow, before
    202 mL/min
    elamipretide
    Stenotic kidney renal blood flow, 3 months
    262 mL/min
    elamipretide

    Source sentences

    Summary
    Stenotic kidney RBF rose (202±29-262±115 mL/min; P=0.04) 3 months after PTRA in the elamipretide-treated group only.
    2 context sentences
    Summary · context
    Inpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA.
    Summary · context
    Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 stopped early · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 1/2Results postedNCT01755858

Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery

Stealth BioTherapeutics Inc.n = 16Dec 2012 to May 2016

Renal Artery Obstruction · Hypertension, Renovascular · Ischemia Reperfusion Injury

Trial pageClinicalTrials.govUpdated 11 Aug 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:47 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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