NCT04181710: OXYOP 2

Evaluation of a Marine OXYgen Carrier for Organ Preservation

Completed NA Last updated 29 November 2023

What this trial tests

NA trial testing Kidney transplant in End Stage Renal Diseases in 490 participants. Completed in 11 September 2023.

Timeline

4 July 2020

Primary endpoint
12 July 2022

11 September 2023

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	490
Start date	4 July 2020
Primary completion	12 July 2022
Estimated completion	11 September 2023
Sites	32 locations across France

Drugs / interventions tested

• Kidney transplant

Conditions studied

• End Stage Renal Diseases — all drugs for End Stage Renal Diseases →

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with End Stage Renal Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).

The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (\~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.

Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.

In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.

The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in kidney transplantation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current perspectives of artificial oxygen carriers as red blood cell substitutes: a review of old to cutting-edge technologies using in vitro and in vivo assessments.
   Mohanto N, Park YJ, Jee JP. · · 2023 · cited 25× · PMID 35935469 · DOI 10.1007/s40005-022-00590-y
2. Combating hypoxemia in COVID-19 patients with a natural oxygen carrier, HEMO₂Life® (M101).
   Lupon E, Lellouch AG, Zal F, Cetrulo CL, et al · · 2021 · cited 13× · PMID 33308935 · DOI 10.1016/j.mehy.2020.110421
3. Therapeutic delivery of oxygen using artificial oxygen carriers demonstrates the possibility of treating a wide range of diseases.
   Mohanto N, Mondal H, Park YJ, Jee JP. · · 2025 · cited 12× · PMID 39827150 · DOI 10.1186/s12951-024-03060-9
4. Evaluation of the efficacy of HEMO₂life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial.
   Le Meur Y, Nowak E, Barrou B, Thierry A, et al · · 2023 · cited 10× · PMID 37127632 · DOI 10.1186/s13063-023-07302-3
5. The artificial oxygen carrier erythrocruorin-characteristics and potential significance in medicine.
   Kruczkowska W, Kciuk M, Pasieka Z, Kłosiński K, et al · · 2023 · cited 7× · PMID 37460699 · DOI 10.1007/s00109-023-02350-3
6. Does Oxygen Work? Evidence for Oxygenation During Kidney Graft Preservation: A Review.
   Calva Lopez A, Robles Garcia JE, Yanez Ruiz CA, Tapia Tapia MD, et al · · 2025 · cited 1× · PMID 40142735 · DOI 10.3390/jcm14061927
7. Improving kidney transplantation through the addition of pharmacological agents to hypothermic preservation solutions: a scoping review.
   Mayoral V, Darius T, Bruneau S, Masset C, et al · · 2025 · PMID 41657778 · DOI 10.3389/fphar.2025.1692398
8. Biosynthetic blood surrogates: Current status and future opportunities.
   Disharoon D, Rohiwal S, Hernandez S, Paruchuri BC, et al · · 2025 · PMID 41244334 · DOI 10.1002/btm2.70084