Quality of life in kidney transplant recipients with Hepatitis C Virus (HCV) infection
| ISRCTN | ISRCTN97560076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97560076 |
| Protocol serial number | 290/15 |
| Sponsor | Comitato Etico "Carlo Romano", Università Federico II di Napoli |
| Funder | Investigator initiated and funded |
- Submission date
- 01/08/2018
- Registration date
- 08/08/2018
- Last edited
- 11/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
There is an association between kidney disease and infection with hepatitis C virus (HCV) - sometimes, patients may develop kidney disease as a result of HCV infections; sometimes, they may develop HCV infection through their kidney disease.
Recently, there has been introduction of direct anti-HCV drugs that have radically changed the course of this infection in patients with kidney disease. HCV infection can cause physical and psychological issues for patients. The aim of this study is to determine whether these anti-HCV drugs can improve quality of life for patients with HCV infection after kidney transplantation through eradication of HCV.
Who can participate?
Adult kidney transplant recipients who are infected with HCV and are being treated in the Nephrology and Transplant Unit of the University Federico II of Naples, Italy
What does the study involve?
Participants will be asked to complete 2 questionnaires about quality of life before starting anti-HCV therapy, after its completion (12 weeks after beginning therapy) and 1 year after its completion.
What are the possible benefits and risks of participating?
The benefit to participants taking part in this study is that the anti-HCV treatment will treat the infection and therefore should improve quality of life. The possible risks of participating are the minimal side effects associated with the anti-HCV therapy used, including headaches and gastrointestinal symptoms.
Where is the study run from?
University Federico II, Naples, Italy
When is the study starting and how long is it expected to run for?
October 2015 to February 2018
Who is funding the study?
This study is self-funded
Who is the main contact?
Prof Massimo Sabbatini
sabbatin@unina.it
Contact information
Public
University Federico II of Naples
Naples
80131
Italy
 ORCID ID |
0000-0003-1339-9228 |
|---|---|
| Phone | +30 081 746 2614 |
| sabbatin@unina.it |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational longitudinal case series |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Eradication of HCV in Renal Transplant Recipients and its effects on Quality of Life |
| Study objectives | To test the effects of HCV eradication on quality of life (QoL) in renal transplant recipients (RTR) |
| Ethics approval(s) | Ethical Committee of “Federico II” University, 26/02/2016, 290/15 |
| Health condition(s) or problem(s) studied | Hepatitis C Virus in long term renal transplant recipients |
| Intervention | Participants will be asked to complete 2 different quality of life questionnaires (36-item Short Form Survey (SF36) and Chronic Liver Disease Questionnaire (CLDQ)) at the baseline, at the end of antiviral therapy (12 weeks) and 1 year after its completion. The anti-HCV therapy will be a sofosbuvir-based regimen. |
| Intervention type | Other |
| Primary outcome measure(s) |
Improvements in the different domains (physical and emotional) of quality of life after viral eradication, assessed at the end of HCV antirviral therapy (12 weeks) and 1 year after its completion using the following: |
| Key secondary outcome measure(s) |
Kidney function, assessed by the stability of calculated glomerular filtration rate (eGFR), calculated using the CKD-EPI creatinine equation at the baseline, at the end of antiviral therapy (12 weeks) and 1 year after its completion. |
| Completion date | 10/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Stable eGFR > 30 ml/min 3. Moderate liver stiffness (measured by elastography) 4. Replicating HCV infection |
| Key exclusion criteria | 1. Decompensated liver cirrhosis 2. Chronic hepatitis B 3. Human immunodeficiency virus infection 4. Presence of specific intercurrent clinical problems |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Italy
Study participating centre
Naples
80131
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and analyses during the current study are available upon reasonable request from Prof. Massimo Sabbatini (sabbatin@unina.it) for the next 12 months, for evaluation of both raw data and of statistical analysis, to discuss together. Patients gave their informed consent to anonymous divulgation of their data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/08/2018 | 11/03/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/03/2019: The following changes have been made:
1. Publication reference added.
2. The Total final enrolment number has been added from the results publication.
