Clinical trial • Phase III • Cardiology

L-GLUTAMIC ACID for Acute kidney injury | Heart failure | Ischemic heart disease

Phase III trial of L-GLUTAMIC ACID for Acute kidney injury | Heart failure | Ischemic heart disease.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Acute kidney injury | Heart failure | Ischemic heart disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-06-2024
First CTIS Authorization Date
05-09-2024

Trial design

Randomised, placebo: sodium chloride (0.9% sodium chloride solution for intravenous infusion), intravenous; test: l-glutamic acid (l-glutamic acid solution 0.125m for intravenous infusion), intravenous infusion. randomized 1:1. (specific dosing schedule not specified in the record; product info indicates l-glutamic acid max daily dose 9 g.)-controlled Phase III trial across 5 sites in Sweden.

Randomised
Yes
Comparator
Placebo: SODIUM CHLORIDE (0.9% Sodium Chloride solution for intravenous infusion), intravenous; Test: L-GLUTAMIC ACID (L-Glutamic acid solution 0.125M for intravenous infusion), intravenous infusion. Randomized 1:1. (Specific dosing schedule not specified in the record; product info indicates L-Glutamic acid max daily dose 9 g.)
Target Sample Size
380

Eligibility

Recruits 380 No vulnerable population selected; trial includes adults only. Exclusion: "informed consent not possible because of critical condition or other reason"..

Vulnerable Population
No vulnerable population selected; trial includes adults only. Exclusion: "informed consent not possible because of critical condition or other reason".

Inclusion criteria

  • {"criterion_text":"- Adult patients without diabetes operated on heart-lung machine with CABG of at least two vessel disease or left main stenosis with or without a concomitant procedure and who either have EuroSCORE II ≥ 3.0 to which at least one cardiac or procedure related risk factor contribute or Left Ventricular Ejection Fraction ≤ 0.30 regardless of EuroSCORE II"}

Exclusion criteria

  • {"criterion_text":"- Diabetes"}
  • {"criterion_text":"- ambiguous food allergy known to have elicited flushing, headache, rash or asthma"}
  • {"criterion_text":"- age > 85 years"}
  • {"criterion_text":"- previous cardiac surgery"}
  • {"criterion_text":"- informed consent not possible because of critical condition or other reason"}
  • {"criterion_text":"- preoperative use of inotropic support or mechanical circulatory assist"}
  • {"criterion_text":"- preoperative dialysis or calculated Creatinine clearance < 30 mL/min"}
  • {"criterion_text":"- surgery without heart-lung machine (off-pump)"}
  • {"criterion_text":"- concomitant Maze-procedure"}
  • {"criterion_text":"- surgery of ascending aorta necessitating circulatory arrest"}
  • {"criterion_text":"- surgery of both aortic and mitral valve"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of postoperative acute kidney injury (AKI) measured as >= 50% postoperative increase of p-creatinine compared to preoperative value","definition_or_measurement_approach":"Measured as >= 50% postoperative increase of plasma creatinine compared to preoperative value"}

Secondary endpoints

  • {"endpoint_text":"- Postoperative increase of p-NT-proBNP from the day before surgery to the third postoperative day","definition_or_measurement_approach":"Change in plasma NT-proBNP from the day before surgery to postoperative day 3"}

Recruitment

Planned Sample Size
380
Recruitment Window Months
27
Consent Approach
Informed consent required from participants. Exclusion includes "informed consent not possible because of critical condition or other reason." No information on assent or age-specific consent documents or languages available.

Geography

Total Number Of Sites
5
Total Number Of Participants
380

Sweden

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
05-09-2024
Processing Time Days
80
Number Of Sites
5
Number Of Participants
380

Sites

Site Name
Uppsala University Hospital
Department Name
Thoraxkliniken
Contact Person Name
Karl-Henrik Grinnemo
Contact Person Email
karl-henrik.grinnemo@uu.se
Site Name
Region Oestergoetland
Department Name
Thorax-kärlkliniken
Contact Person Name
Farkas Vanky
Site Name
Region Oerebro Laen
Department Name
Kärl och Thorax
Contact Person Name
Vidlund Mårten
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Thorax & Kärl
Contact Person Name
Dardashti Alain
Contact Person Email
alain.dardashti@med.lu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Thorax
Contact Person Name
Jeppsson Anders
Contact Person Email
anders.jeppsson@vgregion.se

Sponsor

Primary sponsor

Full Name
Region Oestergoetland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
L-GLUTAMIC ACID
Active Substance
L-GLUTAMIC ACID
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Dose Levels
Reported product information includes max daily dose 9 g (dose unit: g); formulation: L-Glutamic acid solution 0.125M for intravenous infusion
Maximum Dose
9 g (max daily dose reported)
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Dose Levels
Formulation: 0.9% Sodium Chloride solution for intravenous infusion; reported max total dose 500 ml
Maximum Dose
500 ml (max total dose reported)

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