Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment.

A Single-Center, Open-Label Study to Evaluate the Renal Function Improvement in Lamivudine Long Term Used HBsAg Positive Kidney Transplantation Patients After Switch to Telbivudine Treatment.

The hepatitis B virus (HBV) infection rate among renal transplant recipients was reported from 3% to 20.9%. And patient survival and graft survival rates following renal transplantation may be worsen in HBsAg-positive carriers than in HBsAg-negative recipients. Due to viral replication in asymptomatic HBV carriers induced by post-transplant immunosuppression, liver-related complications, such as liver failure and bleeding, account for 37% to 57% of the mortality cases in HBsAg-positive renal allograft recipients.

Since the late 1990s, Lamivudine has been recognized as an effective and well-tolerated antiviral drug for chronic HBV infection. Lamivudine treatment among HBsAg-positive renal allograft recipients has significantly improved patient survival rates during short-term follow-up. Telbivudine is another approved nucleoside antiviral agent for patients with chronic hepatitis B (CHB). Recently, it was shown that eGFR was improved in HBV-related decompensated cirrhosis patients after 52 weeks Telbivudine treatments. Additional eGFR increase was also observed in Lamivudine experienced CHB patients after switch to Telbivudine treatment.

However, limited results were known about the renal function affected by oral anti-HBV drugs when patients received kidney transplantation. Therefore, we would like to conduct this study to evaluate the renal function of Lamivudine long term used HBsAg positive patients received kidney transplantation after switch to Telbivudine treatment. The clinical and virological outcomes will provide valuable insights of clinical practice.

Study Overview

• Status: Terminated
• Conditions: HBsAg-positive Renal Allograft Recipients
• Intervention / Treatment: Drug: Lamivudine; Drug: Telbivudine

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Kidney transplant patients who are treated with Lamivudine over 6 months (Considering include post kidney transplantation > 6 months with stable calcineurin inhibitors level
2. Seropositive of HBsAg for 6 months
3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Hepatitis cirrhosis patients
2. Co-infection with hepatitis C virus or HIV
3. Pregnant or nursing
4. YMDD resistant at baseline
5. ABO incompatible renal transplantation
6. Cross match positive
7. Poor renal function at baseline (eGFR<20)
8. Known hypersensitivity or intolerance to any of the ingredients in Telbivudine
9. Known history of Telbivudine resistance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: lamivudine; HBsAg (+) patients received renal transplant and under lamivudine therapy.	Drug: Lamivudine; Other Names: Zeffix
Active Comparator: telbivudine; HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later.	Drug: Telbivudine; Other Names: Sebivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the renal function in HBsAg positive kidney transplant patients in Telbivudine and Lamivudine treatment groups by eGFR at 48 Weeks after treatment using MDRD formula.	48 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: September 5, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 5, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine; Telbivudine
• Other Study ID Numbers: 201310070MINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES