Evidence map›Paper›PMID 28916603›Full record

Trial reportCirculation. Cardiovascular interventions2017

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

Ahmed Saad, Sandra M S Herrmann, Alfonso Eirin, Christopher M Ferguson, James F Glockner, Haraldur Bjarnason, Michael A McKusick, Sanjay Misra, Lilach O Lerman, Stephen C Textor

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Circulation. Cardiovascular interventions, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01755858 (A Phase 2a, Placebo-controlled Trial to Evaluate the Impact of Intravenous Bendavia™ on Ischemia Reperfusion Injury in Atherosclerotic Renal Artery Stenosis in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery), which is not on this map. Cited by 71 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 2 pooled it
8.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01755858 phase1 / phase2terminatednot on this map

A Phase 2a, Placebo-controlled Trial to Evaluate the Impact of Intravenous Bendavia™ on Ischemia Reperfusion Injury in Atherosclerotic Renal Artery Stenosis in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery

TypeinterventionalSponsorStealth BioTherapeutics Inc.Ran2012 to 2016Enrolled16ConditionsRenal Artery Obstruction, Hypertension, Renovascular, Ischemia Reperfusion InjuryArmsBendavia, Placebo
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
  2. Renal blood oxygenation level-dependent magnetic resonance imaging to measure renal tissue oxygenation: a statement paper and systematic review.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2018
    Pooled it
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  16. When in doubt, pig it out: a versatile translational platform to study CKD, HFpEF, and CKM syndrome.American journal of physiology. Heart and circulatory physiology · 2025
    Review
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  18. Article
  19. Targeting respiratory virus-induced reactive oxygen species in airways diseases.European respiratory review : an official journal of the European Respiratory Society · 2025
    Review
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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Ahmed SaadFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Sandra M S HerrmannFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Alfonso EirinFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Christopher M FergusonFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
James F GlocknerFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Haraldur BjarnasonFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Michael A McKusickFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Sanjay MisraFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Lilach O LermanFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN.
Stephen C TextorFrom the Division of Nephrology and Hypertension (A.S., S.M.S.H., A.E., C.M.F., L.O.L., S.C.T.) and Department of Radiology (J.F.G., H.B., M.A.M., S.M.), Mayo Clinic, Rochester, MN. stextor@mayo.edu.
Mayo Clinic · US

Funding

MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
CT imaging for the assessment of kidney injury distal to renal artery stenosisR01DK073608 · NIDDK · MAYO CLINIC ROCHESTER · PI LERMAN, LILACH O · 2006 to 2015
$3.1M
Hypoxia and inflammatory injury in human renovascular hypertensionR01DK100081 · NIDDK · MAYO CLINIC ROCHESTER · PI LERMAN, LILACH O, TEXTOR, STEPHEN C · 2014 to 2018
$2.8M
A potential role for mitoprotection in preserving the kidney in metabolic syndrome and renal artery stenosisK08DK106427 · NIDDK · MAYO CLINIC ROCHESTER · PI EIRIN, ALFONSO · 2015 to 2019
$819k
NCRR NIH HHS UL1 RR024150NIDDK NIH HHS K08 DK106427NIDDK NIH HHS R01 DK073608NIDDK NIH HHS R01 DK100081
6 · The paper itself

Abstract

backgroundAtherosclerotic renal artery stenosis reduces renal blood flow (RBF) and amplifies stenotic kidney hypoxia. Revascularization with percutaneous transluminal renal angioplasty (PTRA) and stenting often fails to recover renal function, possibly because of ischemia/reperfusion injury developing after PTRA. Elamipretide is a mitochondrial-targeted peptide that binds to cardiolipin and stabilizes mitochondrial function. We tested the hypothesis that elamipretide plus PTRA would improve renal function, oxygenation, and RBF in patients with atherosclerotic renal artery stenosis undergoing PTRA. METHODS AND

resultsInpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA. Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8). Stenotic kidney cortical/medullary perfusion and RBF were measured using contrast-enhanced multidetector CT, and renal oxygenation by 3-T blood oxygen level-dependent magnetic resonance imaging before and 3 months after PTRA. Age and basal glomerular filtration rate did not differ between groups. Blood oxygen level-dependent imaging demonstrated increased fractional hypoxia 24 hours after angiography and stenting in placebo (+47%) versus elamipretide (-6%). These were reverted to baseline 3 months later. Stenotic kidney RBF rose (202±29-262±115 mL/min;

conclusionsAdjunctive elamipretide during PTRA was associated with attenuated postprocedural hypoxia, increased RBF, and improved kidney function in this pilot trial. These data support a role for targeted mitochondrial protection to minimize procedure-associated ischemic injury and to improve outcomes of revascularization for human atherosclerotic renal artery stenosis. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01755858.

Indexed as

StentsAgedAngioplasty, BalloonAntioxidantsAtherosclerosisComputed Tomography AngiographyDouble-Blind MethodFemaleGlomerular Filtration RateHumansHypoxiaInfusions, IntravenousKidneyMagnetic Resonance ImagingMaleMiddle AgedAntioxidantsarginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamideOligopeptidesangioplastyhypoxiakidneymagnetic resonance imagingrenal artery stenosisrenovascular hypertensionreperfusion injury

Identifiers

PMID28916603
PMCPMC5659347
OpenAlexW2754496769

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.