Direct Sodium Removal

Direct Sodium Removal (DSR) therapy is Sequana Medical’s novel and proprietary approach under development for the management of volume overload due to heart failure.

Tackling sodium removal directly

The sodium concentration in patients with volume overload is in balance but there is too much sodium and too much fluid in the body.

Sequana Medical’s approach is to remove excess sodium in patients with residual renal function.

As a result, the body acts to restore the sodium concentration in the body by eliminating fluid through urination and osmotic ultrafiltration, resulting in a sustained level of fluid loss.

How to remove the sodium

Sequana Medical’s DSR therapy involves the use of the peritoneal cavity for the removal of sodium via diffusion. To do this, a “sodium-free” solution known as “infusate” is administered to the abdomen and allowed to dwell for a pre-defined period.

During this time, sodium diffuses from the body down a steep diffusion gradient into the infusate. Circulation keeps the effective blood sodium concentration high. The infusate and the extracted sodium are then removed, resulting in a removal of sodium from the body. The body responds by eliminating the associated fluid via osmotic ultrafiltration (the movement of water, together with sodium, from the bloodstream to the peritoneal cavity) and/or urination.

Clinical and pre-clinical data

The impact of administering a sodium-free infusate to the peritoneal cavity, and the resulting sodium and fluid removal, was evaluated in a preclinical study with 15 pigs (of which five had experimentally induced heart failure) and in a first-in-human single dose DSR proof-of-concept study.

These studies demonstrated that DSR can result in the removal of large quantities of sodium and fluid in a safe, tolerable and consistent manner.

Pre-clinical DSR study

  • Healthy pigs: removal of approximately 2 litres of fluid (net 1 litre) and 4 grams of sodium, which represents two times the recommended daily sodium intake for adults in the U.S.
  • Heart failure pigs: removal of approximately 5 litres of fluid (net 4 litres) and 14 grams of sodium, which represents the recommended weekly sodium intake for adults in the U.S.

First-in-human single dose DSR proof-of-concept study

  • DSR was safe & well-tolerated in humans
  • There was substantially higher sodium removal with DSR vs standard PD (peritoneal dialysis) solution
  • Results were consistent between the treated patients

Results were selected for a late-breaking abstract session at the Heart Failure 2019 Congress:

Preparations are underway for a repeated dose alfapump® DSR study to commence in H2 2019.

About this research

Clinical research

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