Permselective membrane for treating vascular calcifications in chronic hemodialysis patients

Patent metadata

Field	Value
Publication number	US-9974895-B2
Application number	US-201414511329-A
Country	US
Kind code	B2
Filing date	Oct 10, 2014
Priority date	Oct 17, 2013
Publication date	May 22, 2018
Grant date	May 22, 2018

Abstract

The present disclosure relates to a hemodialysis membrane for the treatment of vascular calcification in hemodialysis patients, especially in chronic hemodialysis patients. The present disclosure further relates to methods of treating vascular calcification in hemodialysis patients, wherein the hemodialysis membrane is characterized in that it comprises at least one hydrophobic polymer and at least one hydrophilic polymer and in that it has a MWRO of between 15 and 20 kD and a MWCO of between 170-320 kD or that the hemodialysis membrane comprises at least one hydrophobic polymer and at least one hydrophilic polymer and has a MWRO of between 8.5 kD and 14.0 kD and a MWCO of between 55 kD and 130 kD.

First claim

The invention claimed is:

1. A method of treating vascular calcification in a hemodialysis patient, comprising withdrawing and bypassing the blood from the patient in a continuous flow into contact with one face of a hemodialysis membrane, simultaneously passing dialysate solution in a continuous flow on an opposite face of the hemodialysis membrane to the side of the hemodialysis membrane in contact with the blood, the flow of the dialysate solution being countercurrent to the direction of flow of blood, and returning the blood into the patient, wherein the hemodialysis membrane comprises at least one hydrophobic polymer and at least one hydrophilic polymer and has a Molecular Weight Rejection Onset (MWRO) of between 15 and 20 kD and a Molecular Weight Cut-Off (MWCO) of between 170-320 kD as determined by dextran sieving before blood contact of the membrane.

2. A method of treating vascular calcification according to claim 1 , wherein the hemodialysis membrane has a MWRO of between 8.5 kD and 14.0 kD and a MWCO of between 55 kD and 130 kD as determined by dextran sieving before blood contact of the membrane.

3. A method of treating vascular calcification according to claim 1 wherein the hemodialysis patient is classified in one of Chronic Kidney Disease (CKD) stages 3, 4 or 5 and has an Agatston score of above 10.

4. The method of treating vascular calcification according to claim 1 , wherein the hemodialysis patient is classified in one of Chronic Kidney Disease (CKD) stages 4 or 5 and has an Agatston score of above 100.

5. The method of treating vascular calcification according to claim 1 wherein the hemodialysis membrane has a pore radius, on the selective layer surface of the membrane, of between 8-12 nm.

6. The method of treating vascular calcification according to claim 2 wherein the hemodialysis membrane has a pore radius, on the selective layer surface of the membrane, of more than 5.5 nm and less than 8.0 nm.

7. The method of treating vascular calcification according to claim 1 wherein the hemodialysis membrane allows passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of from 0.1 to 1.0 in presence of whole blood, based on EN1238 with Q B max and UF 20%.

8. The method of treating vascular calcification according to claim 1 wherein the hemodialysis treatment is performed from 2 to 4 times per week for a period of from 2 to 6 hours.

9. A method of treating vascular calcification according to claim 2 wherein the hemodialysis patient is classified in one of Chronic Kidney Disease (CKD) stages 3, 4 or 5 and has an Agatston score of above 10.

10. The method of treating vascular calcification according to claim 3 wherein the hemodialysis membrane has a pore radius, on the selective layer surface of the membrane, of between 8-12 nm.

11. The method of treating vascular calcification according to claim 4 wherein the hemodialysis membrane has a pore radius, on the selective layer surface of the membrane, of between 8-12 nm.

12. The method of treating vascular calcification according claim 3 wherein the hemodialysis membrane has a pore radius, on the selective layer surface of the membrane, of more than 5.5 and less than 8.0 nm.

13. The method of treating vascular calcification according to claim 1 wherein the hemodialysis patient has an Agatston score of above 10.

14. The method of treating vascular calcification according to claim 13 wherein the membrane has a reduction rate of the patient Agatston score of more than 10%.

15. The method of treating vascular calcification according to claim 13 wherein the membrane has a reduction rate of the patient Agatston score of more than 20%.

16. The method of treating vascular calcification according to claim 13 wherein the membrane has a reduction rate of the patient Agatston score of more than 30%.

17. The method of treating vascular calcification according to claim 1 wherein the membrane has a clearance (ml/min) for κ-free light chains (κ-FLC) of from 30 to 45.

18. The method of treating vascular calcification according to claim 1 wherein the membrane has a clearance (ml/min) for λ-free light chains (λ-FLC) of from 28 to 40.

19. A method of treating vascular calcification in a hemodialysis patient, comprising withdrawing and bypassing the blood from the patient in a continuous flow into contact with one face of a hemodialysis membrane, simultaneously passing dialysate solution in a continuous flow on an opposite face of the hemodialysis membrane to the side of the hemodialysis membrane in contact with the blood, the flow of the dialysate solution being countercurrent to the direction of flow of blood, and returning the blood into the patient, wherein the hemodialysis membrane comprises at least one hydrophobic polymer and at least one hydrophilic polymer and wherein the hemodialysis membrane allows passage of molecules having a molecular weight of up to 45 kDa with a sieving coefficient of from 0.1 to 1.0 in presence of whole blood, based on EN1238 with Q B max and UF 20%.

20. The method of claim 19 , wherein the hemodialysis patient has an Agatston score of >11.

Assignees

• Gambro Lundia Ab
• Univ Berlin Charite

Inventors

• Storr Markus
• Krause Bernd
• Schindler Ralf
• Zickler Daniel
• Hegner Bjoern

Classifications

• B01D2325/38

  Hydrophobic membranes · CPC title

• B01D71/68

  Polysulfones; Polyethersulfones · CPC title

• A61K35/14

  Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42) · CPC title

• A61M1/16 Primary

  with membranes · CPC title

• B01D69/08

  Hollow fibre membranes (manufacture of hollow fibres D01D5/24, D01F1/08) · CPC title