Reduction of B 2 Microglobulin in Hemodialysis Patients

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1 R43 DK48612-1,
Agency Tracking Number: 25044
Amount: $71,949.00
Phase: Phase I
Program: SBIR
Awards Year: 1994
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
University Medical Associates
530 S Jackson Street, Louisville, KY, 40202
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Elias Klein
 (502) 588-5243
Business Contact
Phone: () -
Research Institution
More than 100,000 patients now receive chronic hemodialysis therapy in Medicare's End StageRenal Disease Program. Hemodialysis related amyloidosis affects a significant portion of these patients.The syndrome presents clinically as carped tunnel syndrome, cystic bone lesions, and arthropathies. Thedisorder has been identified with excessive circulating and stored quantities of Beta2-microglobulin(Beta2-M). The syndrome cannot be cured, only prevented. Phase I describes experiments to identifyand characterize sorbent materials which can be used in conjunction with the patients' normal dialysistreatment to reduce body burdens of Beta2-M. Phase II aims will be to establish flow and sorbentvolume criteria for the reduction of Beta2-M in conjunction with normal hemodialysis. In Phase III clinicaltrials, mass balances in the clinical setting will be used to project whether significant clinical benefitswill accrue to the dialysis patients. Clinically significant reduction of Beta2-M at an affordable cost isthe long term aim of this program. Based on daily generation rates, estimates at 200 mg/70 kg patient,required sorbent capabilities of 200-300 mg Beta2-M/dialysis are projected. Such reduction, augmentingBeta2-M removal by high flux dialyzers, should provide a measurable benefit to this patient population.

* information listed above is at the time of submission.

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