Renoprotective Effects of Telbivudine in Chronic Hepatitis B

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Renal impairment is common in patients with chronic hepatitis B infection. For those taking nucleotide analogues, renal toxicity of adefovir disoproxil (ADV) and tenofovir disoproxil fumarate (TDF) is a significant concern in chronic hepatitis B (CHB) patients. Early observational clinical data suggested that telbivudine (LdT) might have renoprotective effects. In this prospective study, consecutive CHB patients on combined lamivudine (LAM)+ADV/TDF are switched to LdT+ADV/TDF at recruitment and are followed up for 24 months. Estimated glomerular filtration rate (eGFR) is calculated with the Modification of Diet in Renal Disease (MDRD) equation. The effects of LdT on cell viability and expression of kidney injury or apoptotic biomarkers are investigated in cultured renal tubular epithelial cell line HK-2.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Lamivudine; Telbivudine; Tenofovir

Criteria

Inclusion Criteria:

1. Age 18 - 70 years

2. Documented HBsAg positivity for at least 6 months. Patients can be either HBeAg positive AND HBV DNA < 9 log10 copies/mL or HBeAg negative AND HBV DNA < 7 log10 copies/mL

3. On combination therapy (lamivudine and tenofovir or lamivudine and adefovir) for at least 1 year

4. Documented serum creatinine at least in 2 separate occasions in the last 1 year before recruitment

5. MDRD eGFR 30-89ml/min at baseline

Exclusion Criteria:

1. Concomitant liver disease including chronic hepatitis C and/or D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis

2. Significant alcohol intake or drug abuse

3. Pregnant subjects

4. Patients with co-existing significant chronic kidney disease (e.g.post renal transplantation etc.)

5. Allergic to any of the medications involved in the study