Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

November 8, 2019 updated by: Safak Mirioglu, Istanbul University

Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Study Group
Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR12
Time Frame: 6 months
Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-12 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Chair: Sabahattin Kaymakoglu, MD, Department of Internal Medicine, Istanbul Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

June 15, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C, Chronic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe