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

NCT02894554 | Terminated Phase 4

• 1 other identifier: 201310070MINA
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HBsAg-positive Renal Allograft Recipients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

lamivudine

PLACEBO COMPARATOR

HBsAg (+) patients received renal transplant and under lamivudine therapy.

Drug: Lamivudine

telbivudine

ACTIVE COMPARATOR

HBsAg (+) patients received renal transplant and under lamivudine therapy and then switch to telbivudine 6 months later.

Drug: Telbivudine

Interventions

Telbivudine DRUG

Also known as: Sebivo

telbivudine

Lamivudine DRUG

Also known as: Zeffix

lamivudine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hepatitis cirrhosis patients
• Co-infection with hepatitis C virus or HIV
• Pregnant or nursing
• YMDD resistant at baseline
• ABO incompatible renal transplantation
• Cross match positive
• Poor renal function at baseline (eGFR\<20)
• Known hypersensitivity or intolerance to any of the ingredients in Telbivudine
• Known history of Telbivudine resistance

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Interventions

Telbivudine; Lamivudine

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Dideoxynucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: September 9, 2016
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share