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

Primary Purpose

Acute Kidney Injury (AKI)

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

RMC-035

Placebo

About this trial

This is an interventional prevention trial for Acute Kidney Injury (AKI) focused on measuring AKI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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

Key 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)

Sites / Locations

Münster University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RMC-035

Placebo

Arm Description

Participants will receive RMC-035 intravenously

Participants will receive matching placebo solution intravenously

Outcomes

Primary Outcome Measures

Nature, frequency and severity of AEs

• To evaluate the safety and tolerability of RMC-035 in subjects undergoing non-emergent, on-pump Coronary Artery Bypass Graft (CABG) and/or valve surgery

Secondary Outcome Measures

Maximum observed concentration (Cmax)

Analysis of RMC-035

Area under the curve (AUC)

Analysis of RMC-035

Elimination half-life (T1/2)

Analysis of RMC-035

Full Information

NCT ID

NCT04829916

First Posted

March 26, 2021

Last Updated

August 10, 2021

Sponsor

Guard Therapeutics AB

1. Study Identification

Unique Protocol Identification Number

NCT04829916

Brief Title

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

Official Title

A Phase 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

March 16, 2021 (Actual)

Primary Completion Date

July 15, 2021 (Actual)

Study Completion Date

July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guard Therapeutics AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury (AKI)

Keywords

AKI

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RMC-035

Arm Type

Experimental

Arm Description

Participants will receive RMC-035 intravenously

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive matching placebo solution intravenously

Intervention Type

Drug

Intervention Name(s)

RMC-035

Other Intervention Name(s)

Solution for injection

Intervention Description

Multiple dosing during 48 hours following cardiac surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Solution for injection

Intervention Description

Multiple dosing during 48 hours following cardiac surgery

Primary Outcome Measure Information:

Title

Nature, frequency and severity of AEs

Description

• To evaluate the safety and tolerability of RMC-035 in subjects undergoing non-emergent, on-pump Coronary Artery Bypass Graft (CABG) and/or valve surgery

Time Frame

Baseline through day 30

Secondary Outcome Measure Information:

Title

Maximum observed concentration (Cmax)

Description

Analysis of RMC-035

Time Frame

Blood samples will be taken pre-dose and up to 48 hours after start of Dose 1

Title

Area under the curve (AUC)

Description

Analysis of RMC-035

Time Frame

Blood samples will be taken pre-dose and up to 48 hours after start of Dose 1

Title

Elimination half-life (T1/2)

Description

Analysis of RMC-035

Time Frame

Blood samples will be taken pre-dose and up to 48 hours after start of Dose 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key 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 Key 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tobias Agervald, MD PhD

Organizational Affiliation

Guard Therapeutics AB

Official's Role

Study Director

Facility Information:

Facility Name

Münster University Hospital

City

Münster

ZIP/Postal Code

DE-481 49

Country

Germany

12. IPD Sharing Statement

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

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