Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant; Complications Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Being a kidney transplant recipient.
Having a detectable level of HCV RNA.
Having direct acting antivirals for 12 or 24 weeks.

Exclusion criteria

Withdrawing or not providing consent.

Treatment and study plan

Primary outcomes

SVR12

Time frame: 6 months

Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.

Secondary outcomes

Stable Graft Function

Time frame: 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

Time frame: 6 months

Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Mar 19, 2019
Registry last updated: Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed