Teprasiran, a Small Interfering RNA, for the Prevention of Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Randomized Clinical Study
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Background: Acute kidney injury (AKI) affects up to 30% of patients undergoing cardiac surgery, leading to increased in-hospital and long-term morbidity and mortality. Teprasiran is a novel small interfering RNA that temporarily inhibits p53-mediated cell death that underlies AKI. Methods: This prospective, multicenter, double-blind, randomized, controlled phase 2 trial evaluated the efficacy and safety of a single 10 mg/kg dose of teprasiran versus placebo (1:1), in reducing the incidence, severity, and duration of AKI after cardiac surgery in high-risk patients. The primary end point was the proportion of patients who developed AKI determined by serum creatinine by postoperative day 5. Other end points included AKI severity and duration using various prespecified criteria. To inform future clinical development, a composite end point of major adverse kidney events at day 90, including death, renal replacement therapy, and ≥25% reduction of estimated glomerular filtration rate was assessed. Both serum creatinine and serum cystatin-C were used for estimated glomerular filtration rate assessments. Results: A total of 360 patients were randomly assigned in 41 centers; 341 dosed patients were 73±7.5 years of age (mean±SD), 72% were men, and median European System for Cardiac Operative Risk Evaluation score was 2.6%. Demographics and surgical parameters were similar between groups. AKI incidence was 37% for teprasiran- versus 50% for placebo-treated patients, a 12.8% absolute risk reduction, P =0.02; odds ratio, 0.58 (95% CI, 0.37–0.92). AKI severity and duration were also improved with teprasiran: 2.5% of teprasiran- versus 6.7% of placebo-treated patients had grade 3 AKI; 7% teprasiran- versus 13% placebo-treated patients had AKI lasting for 5 days. No significant difference was observed for the major adverse kidney events at day 90 composite in the overall population. No safety issues were identified with teprasiran treatment. Conclusions: The incidence, severity, and duration of early AKI in high-risk patients undergoing cardiac surgery were significantly reduced after teprasiran administration. A phase 3 study with a major adverse kidney event at day 90 primary outcome that has recently completed enrollment was designed on the basis of these findings (NCT03510897). Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02610283.
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I5NP (QPI-1002), also known as teprasiran, is an siRNA targeting mutant-specific p53 for the treatment of kidney acute renal failure.
“I5NP (QPI-1002) (237), also known as teprasiran, is an siRNA that targets mutant-specific p53 developed by Quark Pharmaceuticals for the treatment of kidney acute renal failure (NCT00683553).570”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [570]
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- Authors
- Thielmann, M., Corteville, D., Szabo, G., Swaminathan, M., Lamy, A., Lehner, L. J., Brown, C. D., Noiseux, N., Atta, M. G., Squiers, E. C., Erlich, S., Rothenstein, D., Molitoris, B., & Mazer, C. D.
- Affiliations
- West German Heart and Vascular Center Essen (DE)
- Unity Health System (US)
- University Hospital in Halle (DE)
- Duke University (US)
- McMaster University (CA)
- Charité – Universitätsmedizin Berlin (DE)
- Saint John Regional Hospital (CA)
- Centre Hospitalier de l’Université de Montréal (CA)
- Johns Hopkins University (US)
- Coastal Vista Consulting LLC, Half Moon Bay, CA (E.C.S.).
- Indiana University Indianapolis (US)
- Quark Pharmaceuticals (United States) (US)
- St. Michael's Hospital (CA)
- Corresponding author
- Mazer, C. David
- ORCID
- Venue
- Circulation
- Published
- 2021-10-05
- Volume
- 144
- Issue
- 14
- Pages
- 1133-1144
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- PMC
- PMC8487715
- OpenAlex
- W3197366070
- Cited by
- 97
- References
- 52
- Citations by year
- 2026: 9 · 2025: 22 · 2024: 29 · 2023: 18 · 2022: 18 · 2021: 1
- FWCI
- 11.30
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Circulation (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion, cc-by-nc-nd)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Pathology and Forensic Medicine › Chemotherapy-induced organ toxicity mitigation
- Keywords
- siRNA, acute kidney injury, cardiac surgery, p53 inhibition, high-risk patients, major adverse kidney events, renal replacement therapy, estimated glomerular filtration rate, serum creatinine, cystatin C
- MeSH terms
- Aged, Double-Blind Method, Female, Heart Diseases, Humans, Male, RNA, Small Interfering, Acute Kidney Injury
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