RMC-035

DRUG4 trials

Sponsors

Guard Therapeutics International AB (publ), Guard Therapeutics AB

Conditions

Acute Kidney InjuryAcute Kidney Injury (AKI)Kidney Injury Following Open-Chest Cardiac SurgeryLoss of renal function following cardiac surgery

Phase 1

A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery

CompletedNCT04829916

Guard Therapeutics ABAcute Kidney Injury (AKI)

Start: 2021-03-16End: 2021-07-15Updated: 2024-04-23

Phase 2

Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery

TerminatedNCT05126303

Guard Therapeutics ABAcute Kidney Injury

Start: 2022-03-31End: 2023-07-12Updated: 2024-05-16

A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery

CompletedNCT06475274

Guard Therapeutics ABKidney Injury Following Open-Chest Cardiac Surgery

Start: 2024-08-26End: 2025-09-11Updated: 2025-10-02

A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery

CompletedCTIS2024-510658-28-00

Guard Therapeutics International AB (publ)Loss of renal function following cardiac surgery

Start: 2024-09-24End: 2025-09-05Target: 124Updated: 2025-05-22

Related Papers

POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery.

2025-10-28

#644 A phase 2b dose finding study to assess the efficacy of RMC-035 on renal function in participants at high risk for kidney injury following open-chest cardiac surgery (POINTER)

Nephrology Dialysis Transplantation2025-10-01

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.

2024-09-164 citations

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 Open2023-04-013 citations