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Organ Preservation Media Investigation

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Completed
Phase 1

Conditions

Kidney Transplant

Treatments

Device: Modified Viaspan

Study type

Interventional

Funder types

Other

Identifiers

NCT00225472
2002-566

Details and patient eligibility

About

Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4) the need for immunomodulating treatments. Improved cold storage methods can significantly impact on the first 3 of these 4 major problems. The device to be tested is a modification of the existing Viaspan organ preservation solution. The modification of this solution combines four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation during cold storage is a significant and previously unrecognized mechanism of injury in cold stored kidneys. The aim of this study is improved graft function, decreasing early graft loss due to rejection, and decreasing the donor organ shortage.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • first renal transplant, PRA's <20%

Exclusion criteria

  • PRA's greater than 20%
  • Subjects who are receiving a non-primary renal transplant
  • Subjects under the age of 18
  • Pregnant or nursing women

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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