Phase 3 Completed N=36 Treatment

Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Chronic Kidney Disease · Hepatitis C · HCV

Source: ClinicalTrials.gov NCT03801707 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcomePrimary: Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment — 28 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment	28	—
PRIMARY Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies	2; 0; 0; 28	—
SECONDARY Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant	54; 46	—
SECONDARY Patient's Survival at 6 and 12 Months	30; 30	—
SECONDARY Graft Survival at 6 and 12 Months	30; 30	—

Eligibility Criteria

Recipient Inclusion/Exclusion Criteria:

Inclusion Criteria

Adult age >18 years able to provide consent
Lack of available living donor
Calculated pre-transplant reactive panel (cPRA) of 20% and 5 years
Listing for multi-organ transplantation
Active or recent history (<6 months) of alcohol abuse or substance abuse
Clinically significant liver disease as determined by principal investigator
History of hepatocarcinoma
Pregnancy or lactation
Refusal to accept blood transfusion
HIV infection
HCV pcr or antibody positive
HBV infection

Donor Inclusion Criteria:

Positive HCV PCR at time of donation
Kidney donor profile index (KDPI)<85%

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03801707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.