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

NCT ID: NCT04829916

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2021-07-15

Brief Summary

The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.

Detailed Description

This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.

Conditions

Acute Kidney Injury (AKI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

RMC-035

Participants will receive RMC-035 intravenously

Group Type: EXPERIMENTAL

RMC-035

Intervention Type: DRUG

Multiple dosing during 48 hours following cardiac surgery

Placebo

Participants will receive matching placebo solution intravenously

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Multiple dosing during 48 hours following cardiac surgery

Interventions

RMC-035

Multiple dosing during 48 hours following cardiac surgery

Intervention Type: DRUG

Placebo

Multiple dosing during 48 hours following cardiac surgery

Intervention Type: DRUG

Other Intervention Names

Solution for injection; Solution for injection

Eligibility Criteria

Inclusion Criteria

• Female and male subjects with an age ≥18 years
• Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)
• Subject has at least ONE of the following risk factors for AKI at screening:

• History of LVEF <35% for at least 3 months prior to screening assessed by either echocardiography, cardiac MRI or nuclear scan.
• History of previous open chest cavity cardiac surgery with or without CPB
• Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug
• Age ≥70 years
• Documented history of heart failure NYHA class II or higher for at least 3 months or longer at screening
• Documented history of previous AKI before date of screening independent of the etiology of AKI
• Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least 3 months prior to screening
• Documented history of albuminuria, defined as UACR >30 mg/g or > 30 mg/24 hour in a 24-hour urine collection.
• eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation

Exclusion Criteria

• Estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline
• Subject has surgery scheduled to be performed without CPB ("off-pump")
• Subject has surgery scheduled for aortic dissection
• Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation
• Subject is scheduled to undergo trans catheter aortic valve implantation (TAVI) or trans catheter aortic valve replacement (TAVR), or single vessel off-pump surgeries or left ventricular device (LVAD) implantation
• Subject has a requirement for any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guard Therapeutics AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Agervald, MD PhD

Role: STUDY_DIRECTOR

Guard Therapeutics AB

Locations

Münster University Hospital

Münster, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

20-ROS-04

Identifier Type: -

Identifier Source: org_study_id