Evidence map›Paper›PMID 29270490›Full record

ArticleKidney international reports2017

Safety and Tolerability Study of an Intravenously Administered Small Interfering Ribonucleic Acid (siRNA) Post On-Pump Cardiothoracic Surgery in Patients at Risk of Acute Kidney Injury.

Segav Demirjian, Gorav Ailawadi, Martin Polinsky, Dani Bitran, Shuli Silberman, Stanton Keith Shernan, Michel Burnier, Marta Hamilton, Elizabeth Squiers, Shai Erlich and 3 more

Open access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Review
  3. Recent Update on siRNA Therapeutics.International journal of molecular sciences · 2025
    Review
  4. Article
  5. Article
  6. Article
  7. Therapeutic siRNA: State-of-the-Art and Future Perspectives.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. RNA Therapeutics - Research and Clinical Advancements.Frontiers in molecular biosciences · 2021
    Review
  13. Article
  14. Therapeutic siRNA: state of the art.Signal transduction and targeted therapy · 2020
    Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. RNA therapy: Are we using the right molecules?Pharmacology & therapeutics · 2019
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 3 countries.

Segav DemirjianCritical Care Nephrology, Cleveland Clinic, Cleveland, Ohio, USA.
Gorav AilawadiAdvanced Cardiac Valve Center, University of Virginia, Charlottesville, Virginia, USA.
Martin PolinskyQuark Pharmaceuticals, Ness Ziona, Israel.
Dani BitranDepartment of Cardiothoracic Surgery, Shaare Zedek Medical Center, Jerusalem, Israel.
Shuli SilbermanDepartment of Cardiothoracic Surgery, Shaare Zedek Medical Center, Jerusalem, Israel.
Stanton Keith ShernanDepartment of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Michel BurnierNephrology and Hypertension Service, Lausanne University Hospital, Lausanne, Switzerland.
Marta HamiltonHamilton Consulting Group LLC, Madison, Wisconsin, USA.
Elizabeth SquiersQuark Pharmaceuticals, Ness Ziona, Israel.
Shai ErlichQuark Pharmaceuticals, Ness Ziona, Israel.
Daniel RothensteinQuark Pharmaceuticals, Ness Ziona, Israel.
Samina KhanQuark Pharmaceuticals, Ness Ziona, Israel.
Lakhmir S ChawlaDivision of Intensive Care Medicine and Division of Nephrology, Department of Medicine, Veterans Affairs Medical Center, Washington, DC, USA.
Shaare Zedek Medical Center · ILCleveland Clinic · USHarvard University · USMadison Group (United States) · USUniversity of Lausanne · CHUniversity of Virginia · USVeterans Health Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients undergoing on-pump cardiac surgery are at an increased risk of acute kidney injury. QPI-1002, a small interfering ribonucleic acid, is under clinical development for the prevention of acute kidney injury. The safety, tolerability, and pharmacokinetics of QPI-1002 was evaluated in this first-in-man, Phase 1 study of a small, interfering ribonucleic acid in patients at risk of acute kidney injury after on-pump cardiac surgery.

methodsIn this phase 1 randomized, placebo-controlled dose-escalation study, a single i.v. dose of QPI-1002 was administered in subjects undergoing on-pump cardiac surgery. Subjects received placebo (

resultsA total of 16 subjects were enrolled in the study. The average maximum concentration and area under the curve from the time of dosing to the last measurable concentration of QPI-1002 were generally dose proportional, indicating that exposure increased with increasing dose. The average mean residence time (mean residence time to the last measurable concentration) was 10 to 13 minutes in all 4 drug-dosing cohorts. Adverse events occurred at a similar rate in all study groups. Of the total 109 reported adverse events, the events were distributed as 26 in the placebo group and 21, 19, 24, and 19 in the QPI-1002 0.5, 1.5, 5.0, and 10.0 mg/kg groups, respectively. Eight of the 16 subjects experienced at least 1 serious adverse event: 4 (100%) in the placebo group and 4 (33.3%) in the combined QPI-1002 cohorts. DISCUSSION: QPI-1002 was rapidly eliminated from plasma. QPI-1002 was safe and well tolerated across all dose groups. Overall, no dose-limiting toxicities or safety signals were observed in the study. Further development of QPI-1002 for prophylaxis of acute kidney injury is warranted.

Indexed as

acute kidney injurycardiopulmonary bypassclinical trialoligonucleotidepharmacokineticssiRNA

Identifiers

PMID29270490
PMCPMC5733816
OpenAlexW2609999900

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.