Multi-center Study to Transplant Hepatitis-C Infected Kidneys (MYTHIC)

Raymond Chung

Status and phase: Completed; Phase 4

Conditions: Hepatitis C; Renal Failure Chronic

Treatments: Drug: glecaprevir/pibrentasvir treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03781726

2018P003140

Details and patient eligibility

About

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.

Full description

The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Enrollment: 30 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment with glecaprevir/pibrentasvir Fixed Dose Combination

Experimental group

Description:

8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir

Treatment:

Drug: glecaprevir/pibrentasvir treatment