Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
Summary
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.
Timeline
- Start
- 2022-03-31
- Primary completion
- 2023-04-15
- Completion
- 2023-07-12
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
Stopped (Enrollment): “Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint”
paper In this proof-of-concept study, RMC-035 did not reduce AKI 72 h after cardiac surgery. reads as missed primary endpoint PMID 39318788 ↗
release “som förväntat nåddes inte det primära (kortsiktiga) effektmåttet, incidens av akut njurskada” reads as missed primary endpoint guardtherapeutics.com ↗
release “Resultaten från en placebo-kontrollerad fas 2-studie (AKITA) av RMC-035 omfattande 177 patienter visade statistiskt signifikant och kliniskt relevant njurskyddande behandlingseffekt” reads as met primary endpoint guardtherapeutics.com ↗
release “Resultat från fas 2-studien AKITA, där 177 patienter inkluderades, visade en statistiskt signifikant och kliniskt relevant gynnsam effekt” reads as met primary endpoint guardtherapeutics.com ↗
Publications
- Zarbock A, Larsson TE, Noiseux N, Mazer CD, Bohm J, Laflamme M, Matschke K, Burkert J, de Varennes B, Myjavec A, Boning A, Koyner JL, Engelman D, Reusch M, Thielmann M; AKITA investigators. Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial. EClinicalMedicine. 2024 Sep 16;76:102830. doi: 10.1016/j.eclinm.2024.102830. eCollection 2024 Oct.
- Mazer CD, Siadati-Fini N, Boehm J, Wirth F, Myjavec A, Brown CD, Koyner JL, Boening A, Engelman DT, Larsson TE, Renfurm R, de Varennes B, Noiseux N, Thielmann M, Lamy A, Laflamme M, von Groote T, Ronco C, Zarbock A. Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial). BMJ Open. 2023 Apr 6;13(4):e068363. doi: 10.1136/bmjopen-2022-068363.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RMC-035 | Protein / enzyme biologic | 0.65 mg/kg | Intravenous |