Human study PLS-00122

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

Randomized controlled trial · 16 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) During Stent Revascularization in Patients With Atherosclerotic Renal Artery Stenosis.primary · Circulation. Cardiovascular interventions · 2017-09-01 · PMID 28916603 · DOI
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Arteryregistry entry · NCT01755858 (TERMINATED, results posted, planned enrollment 16)

Design and participants

Design: Randomized controlled trial
Population: Patients with severe atherosclerotic renal artery stenosis scheduled for percutaneous transluminal renal angioplasty (PTRA) and stenting; age and baseline glomerular filtration rate did not differ between groups.
Conditions: Atherosclerotic renal artery stenosis, Renovascular hypertension, Ischemia/reperfusion injury
Setting: Inpatient studies around renal artery angioplasty and stenting, with imaging before and 3 months after PTRA
Planned enrollment (registry): Not reported
Enrolled: 16
Randomized: Not reported
Completed follow-up: Not reported
Funding: Not stated
Authors’ conflicts: Not stated

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

Elamipretide (intervention) · elamipretide · Elamipretide, a mitochondria-targeted peptide, given as an intravenous infusion before and during PTRA · intravenous · Before and during the PTRA procedure · 6 assigned
Placebo (comparator) · Placebo given before and during PTRA · placebo · intravenous · Before and during the PTRA procedure · 8 assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Stenotic kidney fractional hypoxia

unclear outcome · surrogate · 24 hours after angiography and stenting; 3 months · 3-T blood oxygen level-dependent MRI

Placebo: change from baseline 47 — Fractional hypoxia rose by 47% at 24 hours after stenting
Elamipretide: change from baseline -6 — Fractional hypoxia changed by -6% at 24 hours after stenting
Elamipretide vs Placebo: narrative — Hypoxia values reverted to baseline in both groups by 3 months

Stenotic kidney renal blood flow

unclear outcome · surrogate · 3 months after PTRA · Contrast-enhanced multidetector CT

Elamipretide: other, p = 0.04
Placebo: narrative — A rise in renal blood flow was reported only in the elamipretide group

Estimated glomerular filtration rate

unclear outcome · surrogate · 3 months · Estimated GFR

Elamipretide: narrative, p = 0.003 — eGFR increased over 3 months
Placebo: narrative, p = 0.11 — eGFR change over 3 months was not significant

Systolic blood pressure

unclear outcome · surrogate · 3 months · Systolic blood pressure

Elamipretide vs Placebo: narrative — Systolic blood pressure decreased more in the elamipretide group than in the placebo group

Stenotic kidney cortical and medullary perfusion

unclear outcome · surrogate · Before and 3 months after PTRA · Contrast-enhanced multidetector CT

No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: Not reported in the abstract; the registry entry indicates results are posted, but no safety data are included in the record.

The authors concluded (paraphrased): Adding elamipretide during renal angioplasty and stenting was associated with less post-procedure kidney hypoxia, higher renal blood flow and better kidney function in this pilot trial. The authors say this supports mitochondrial protection to limit procedural ischemic injury.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

small or imprecise: Only 6 elamipretide and 8 placebo patients were reported, so the estimates are very imprecise.
inappropriate endpoint: All reported outcomes are imaging, eGFR and blood pressure surrogates, with no patient-important clinical outcomes.
selective reporting: eGFR and renal blood flow are reported as within-group p-values rather than as between-group contrasts.
incomplete follow up: The registry lists 16 enrolled and the trial as terminated, but the abstract reports 14 patients; analyzed numbers at 3 months are not given.
short follow up: Outcomes were assessed only up to 3 months after PTRA.
inadequate blinding: A placebo was used, but blinding of patients, staff and imaging assessors is not described in the abstract.
abstract only: Only the PubMed abstract and registry metadata are available; the full methods and safety data are not in the record.

Stenotic kidney fractional hypoxia: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization is indicated only by the publication type; sequence generation and concealment are not described, though age and baseline GFR were similar.
Deviations from intended interventions	Some concerns	Blinding and adherence are not described beyond use of a placebo infusion during PTRA.
Missing outcome data	Some concerns	The registry reports 16 enrolled in a terminated trial, versus 14 in the abstract; analyzed numbers are not stated.
Measurement of the outcome	Some concerns	BOLD MRI is objective, but blinding of image assessors to allocation is not reported.
Selection of the reported result	Some concerns	Only group percentage changes are given, with no between-group test or prespecified analysis plan shown.

Some concerns in several domains, in a very small pilot trial reported only as an abstract, together amount to high risk.

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Stenotic kidney renal blood flow: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	The randomization method and allocation concealment are not described in the abstract.
Deviations from intended interventions	Some concerns	Blinding of participants and personnel is not described in the record.
Missing outcome data	Some concerns	Numbers analyzed at 3 months are not stated, and the registry shows 16 enrolled in a terminated trial.
Measurement of the outcome	Some concerns	CT-derived blood flow is objective, but assessor blinding is not reported.
Selection of the reported result	High risk of bias	Only a within-group P=0.04 is reported for elamipretide, with no between-group comparison, suggesting selective analysis.

Reliance on a within-group test plus unclear randomization, blinding and attrition gives high risk.

Estimated glomerular filtration rate: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization details are not reported; only age and basal GFR similarity is mentioned.
Deviations from intended interventions	Some concerns	Deviations from intended interventions and blinding are not described in the abstract.
Missing outcome data	Some concerns	The trial was terminated, and the analyzed numbers at 3 months are not given in the record.
Measurement of the outcome	Some concerns	eGFR is a laboratory measure, but awareness of allocation is not reported.
Selection of the reported result	High risk of bias	Within-group p-values (0.003 versus 0.11) are presented in place of a direct between-group comparison.

Selective within-group reporting and unclear trial conduct give high risk.

Systolic blood pressure: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Allocation methods are not described in the abstract, which is the only report available.
Deviations from intended interventions	Some concerns	Blinding, co-interventions and antihypertensive changes are not described.
Missing outcome data	Some concerns	Follow-up numbers at 3 months are unknown, and the registry lists the trial as terminated.
Measurement of the outcome	Some concerns	The blood pressure measurement method and assessor blinding are not reported.
Selection of the reported result	High risk of bias	Only a narrative statement of a greater decrease is given, with no values or statistics.

Narrative-only reporting and unclear conduct give high risk of bias.

Claims this study informs

Improves function in Barth syndrome: not eligible (wrong population) for “Muscle strength, exercise capacity and fatigue”
Improves exercise capacity in primary mitochondrial myopathy: not eligible (wrong population) for “Six-minute walk distance and fatigue”
Is safe for human administration: not eligible (insufficient data) for “Adverse events, including injection-site reactions, and discontinuations”

Where each value comes from

arms: PMID 28916603, abstract (Methods and results, sentence 2) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 28916603, abstract (Conclusions, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 28916603, abstract (Methods and results, sentences 1-2; publication types) · extracted by AI (automated, not verified by a person) · abstract only
limitations: NCT NCT01755858, registry (status terminated, enrollment) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 28916603, abstract (Methods and results, sentence 3) · extracted by AI (automated, not verified by a person) · abstract only
participants: NCT NCT01755858, registry (enrollment (actual) and status) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 28916603, abstract (Methods and results, sentence 2) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 28916603, abstract (Methods and results, sentences 1 and 4) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 28916603, abstract (Methods and results, sentences 5-8) · extracted by AI (automated, not verified by a person) · abstract only

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).