Human study PLS-00124
Urinary mitochondrial DNA copy number identifies renal mitochondrial injury in renovascular hypertensive patients undergoing renal revascularization: A Pilot Study.
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.
- Urinary mitochondrial DNA copy number identifies renal mitochondrial injury in renovascular hypertensive patients undergoing renal revascularization: A Pilot Study.primary · Acta physiologica (Oxford, England) · 2019-03-13 · PMID 30803138 · DOI
Design and participants
- Design
- Other design
- Population
- Patients with renovascular hypertension undergoing percutaneous transluminal renal angioplasty (PTRA), plus healthy volunteers as reference controls.
- Conditions
- Renovascular hypertension, Renal artery stenosis treated by PTRA
- Planned enrollment (registry)
- Not reported
- Enrolled
- 19
- Randomized
- Not reported
- Completed follow-up
- Not reported
- Funding
- Publication types indicate NIH extramural and non-US government research support; specific funders are not named.
- Authors’ conflicts
- Not reported in the record.
Intervention and comparator
What each group received. Related peptides, analogs and combinations are never treated as the compound itself.
- PTRA+ELAM (intervention) · elamipretide · Elamipretide (mitoprotective drug) given as IV infusion during PTRA · intravenous infusion · During the revascularization procedure · 6 assigned
- PTRA+Placebo (comparator) · Vehicle IV infusion during PTRA · placebo · intravenous infusion · During the revascularization procedure · 8 assigned
- Healthy volunteers (comparator) · Healthy volunteers serving as reference controls for urinary mtDNA levels; no PTRA · no treatment · 5 assigned
What the authors reported
As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.
Urinary mtDNA copy number (COX3 and ND1)
primary outcome · surrogate · Before and 24 hours after PTRA · qPCR of urinary mtDNA genes COX3 and ND1
- PTRA+ELAM vs PTRA+Placebo: narrative — The increase in urinary mtDNA 24 hours after PTRA was blunted with elamipretide compared with placebo.
- PTRA+Placebo vs Healthy volunteers: narrative — Baseline urinary mtDNA was elevated in all RVH patients versus healthy volunteers and correlated with serum creatinine.
Systolic blood pressure
secondary outcome · surrogate · 3 months after PTRA · Systolic blood pressure
- PTRA+ELAM vs PTRA+Placebo: narrative — Systolic blood pressure decreased at 3 months only in elamipretide-treated subjects.
Estimated glomerular filtration rate
secondary outcome · surrogate · 3 months after PTRA · eGFR
- PTRA+ELAM vs PTRA+Placebo: narrative — eGFR increased at 3 months only in elamipretide-treated subjects.
Adverse events
None reported. That is not evidence of safety.
Monitoring: Not reported in the abstract.
The authors concluded (paraphrased): PTRA causes an acute rise in urinary mtDNA reflecting renal mitochondrial injury that may impede renal recovery. Mitoprotection with elamipretide might limit this injury and improve renal outcomes after revascularization.
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 vehicle patients; the authors label it a pilot study and report no effect estimates or intervals.
- abstract only: Only the abstract is available in the record, so methods, allocation and statistics cannot be verified.
- confounding: The abstract does not state randomization or blinding, so baseline differences between the small groups may confound the comparisons.
- inappropriate endpoint: Outcomes are urinary mtDNA, blood pressure and eGFR, all surrogate markers rather than patient-important outcomes.
- short follow up: Follow-up extended only to 3 months after a single peri-procedural infusion.
- selective reporting: Results are given only narratively (e.g., changes seen only in the ELAM group), with no between-group statistics and no safety data in the abstract.
- inappropriate population: Renovascular hypertension patients undergoing PTRA differ from the Barth syndrome and mitochondrial myopathy populations in the claims.
No risk-of-bias assessment has been published for this study’s results.
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 (wrong outcome) for “Adverse events, including injection-site reactions, and discontinuations”
Where each value comes from
- arms: PMID 30803138, abstract (Methods, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
- author_conclusion: PMID 30803138, abstract (Conclusions, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
- design: PMID 30803138, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
- limitations: PMID 30803138, title (Title, 'A Pilot Study') · extracted by AI (automated, not verified by a person) · abstract only
- outcomes: PMID 30803138, abstract (Aims, sentence 3; Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
- participants: PMID 30803138, abstract (Methods, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
- population: PMID 30803138, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
- results: PMID 30803138, abstract (Results, sentences 1-3) · 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).