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

NCT04829916 | Completed Phase 1 Results

• 1 other identifier: 20-ROS-04
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury (AKI)

Keywords

AKI

Outcome Measures

Primary Outcomes (2)

• Frequency of Adverse Events (AEs)

  * number (%) of subjects with at least one AE * number (%) of subjects with at least one SAE * number (%) of subjects with at least one Treatment-Emergent AE (TEAE) * number (%) of subjects with at least one serious TEAE * number (%) of subjects with at least one non-serious TEAE * number (%) of subjects with at least one TEAE of special interest * number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP * number (%) of subjects with at least one TEAEs leading to withdrawal of IMP

  Baseline through day 30

• Severity of AEs

  \- Number of TEAEs per category (mild, moderate, severe life-threatening, death)

  Within 4 days from first dose of IMP

Secondary Outcomes (3)

• Maximum Observed Concentration (Cmax)

  Blood samples taken from pre-dose and up to two hours after start of Dose 5

• Area Under the Curve (AUC) 0-24h

  Blood samples taken from pre-dose and up to two hours after start of Dose 5

• Elimination Half-life (T1/2)

  Blood samples taken from pre-dose and up to two hours after start of Dose 5

Study Arms (2)

RMC-035

EXPERIMENTAL

Participants will receive RMC-035 intravenously

Drug: RMC-035

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo solution intravenously

Drug: Placebo

Interventions

RMC-035 DRUG

Multiple dosing during 48 hours following cardiac surgery

Also known as: Solution for injection

RMC-035

Placebo DRUG

Multiple dosing during 48 hours following cardiac surgery

Also known as: Solution for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guard Therapeutics AB: lead

Study Sites (1)

Münster University Hospital

Münster, DE-481 49, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Solutions; Injections

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Guard Therapeutics

trials@guardtherapeutics.com

+46733319438

Study Officials

• Tobias Agervald, MD PhD

  Guard Therapeutics AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: March 16, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: April 23, 2024
• Results First Posted: December 4, 2023

Record last verified: 2024-04

Locations

DE (1)