Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients
- Conditions
- Kidney Transplant; ComplicationsHepatitis C, Chronic
- Registration Number
- NCT03880682
- Lead Sponsor
- Istanbul University
- Brief Summary
Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Being a kidney transplant recipient.
- Having a detectable level of HCV RNA.
- Having direct acting antivirals for 12 or 24 weeks.
- Withdrawing or not providing consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SVR12 6 months Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.
- Secondary Outcome Measures
Name Time Method Stable Graft Function 6-12 months Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals.
Stable Serum Trough Levels of Immunosuppressive Agents 6 months Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.
Trial Locations
- Locations (1)
Istanbul University
🇹🇷Istanbul, Turkey