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NCT03510897
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Phase 3 trial testing teprasiran in Cardiac Surgery in 1,043 participants. Terminated before completion.
14 October 2020
Quick facts
| Lead sponsor | Quark Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,043 |
| Start date | 29 June 2018 |
| Primary completion | 14 October 2020 |
| Estimated completion | 12 April 2021 |
| Sites | 104 locations across France, New Zealand, Belgium, Austria, United Kingdom, Germany, Canada, Australia |
Drugs / interventions tested
- teprasiran — full drug profile →
- Placebo
Conditions studied
- Cardiac Surgery — all drugs for Cardiac Surgery →
Sponsor
Quark Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic siRNA: state of the art.
Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x -
The growth of siRNA-based therapeutics: Updated clinical studies.
Zhang MM, Bahal R, Rasmussen TP, Manautou JE, et al · · 2021 · cited 366× · PMID 33513339 · DOI 10.1016/j.bcp.2021.114432 -
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z -
Exosomal miR-125b-5p deriving from mesenchymal stem cells promotes tubular repair by suppression of p53 in ischemic acute kidney injury.
Cao JY, Wang B, Tang TT, Wen Y, et al · · 2021 · cited 229× · PMID 33859745 · DOI 10.7150/thno.54550 -
Perioperative Acute Kidney Injury.
Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968 -
Paving the Road for RNA Therapeutics.
Dammes N, Peer D. · · 2020 · cited 159× · PMID 32893005 · DOI 10.1016/j.tips.2020.08.004 -
The landscape of nanoparticle-based siRNA delivery and therapeutic development.
Moazzam M, Zhang M, Hussain A, Yu X, et al · · 2024 · cited 116× · PMID 38204162 · DOI 10.1016/j.ymthe.2024.01.005 -
RNA therapy: Are we using the right molecules?
Yu AM, Jian C, Yu AH, Tu MJ. · · 2019 · cited 109× · PMID 30521885 · DOI 10.1016/j.pharmthera.2018.11.011
Verify or expand the search:
- PubMed search for NCT03510897
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
- NCT07116343 — Intrapleural Ropivacaine Infusion in Cardiac Surgery · Phase 4 · recruiting
- NCT07354841 — Safety and Performance Evaluation of CPB Venous and Arterial Cannulas · NA · recruiting
Other Quark Pharmaceuticals trials
Trials by the same sponsor.
- NCT04654221 — Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery · terminated
- NCT02610296 — QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant · Phase 3 · completed
- NCT02341560 — Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Isc · Phase 2, PHASE3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03510897 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Quark Pharmaceuticals
- Last refreshed: 16 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03510897.
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