Multi-center Study to Transplant Hepatitis-C Infected Kidneys

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Raymond Chung; Raymond T. Chung, MD
• Collaborators: AbbVie; Johns Hopkins University; Northwestern University; University of Cincinnati; University of Michigan; University of Pennsylvania; Weill Medical College of Cornell University

Criteria

Recipient Inclusion Criteria:

• Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2

• Listed for an isolated kidney transplantation

• Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent

• No available medically acceptable, compatible living kidney donor

• Subject must agree to use an effective method of birth control per protocol specifications

Recipient Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant

• Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study

• History of HIV

• HCV RNA positive

• HBV surface Ag-positive or detectable HBV DNA

• Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team

• Presence of clinically significant liver disease

• Transplant candidate requiring antibody desensitization protocol for transplantation

• Most recent calculated panel reactive antibody (cPRA) >80%.

• Prior recipient of a non-renal solid organ transplant

Donor Organ Inclusion Criteria

• Deceased donor organ with kidney donor profile index (KDPI) ≤0.85

• HCV RNA-positive

Donor Organ Exclusion Criteria

• Known prior HCV treatment with direct acting antiviral medication

• HIV RNA-positive

• HBV Surface antigen-positive or HBV DNA-positive