Norfolk, VA

DaVita Clinical Research

Calciphylaxis

Renal Insufficiency

Chronic Kidney Failure

Chronic Renal Insufficiency

Acute Kidney Injury

SNF472

Nipro

Sanifit

condition

allSponsorName

BRIGHT Research Partners

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational dialyzer.

The primary efficacy objective is to evaluate the performance of the use of the high permeability hemodialyzer series ELISIO™-HX, by showing that the clearance rate of middle molecular weight lambda (λ) free light chain (FLC) is improved by using the investigational dialyzer.

Premarket Clinical Safety Assessment of the ELISIO™-HX

DaVita Clinical Research | Norfolk, VA

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Premarket Clinical Safety Assessment of the ELISIO™-HX

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