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

NCT ID: NCT02894554

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lamivudine

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

Group Type: PLACEBO_COMPARATOR

Lamivudine

Intervention Type: DRUG

telbivudine

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

Group Type: ACTIVE_COMPARATOR

Telbivudine

Intervention Type: DRUG

Interventions

Telbivudine

Intervention Type: DRUG

Lamivudine

Intervention Type: DRUG

Other Intervention Names

Sebivo; Zeffix

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201310070MINA

Identifier Type: -

Identifier Source: org_study_id