The Effect of Telbivudine on Renal Function and Proteinuria in Patients With Chronic Hepatitis B Infection and Chronic Kidney Diseases
Chronic kidney disease (CKD) and chronic viral hepatitis due to hepatitis B virus (HBV) are both major public health problems. Treatment of chronic HBV infection in CKD patients, however, is not well defined because of insufficient data from clinical trials. Telbivudine is a new antiviral that provides effective and sustained viral suppression in patients with compensated chronic hepatitis B infection. Unlike other nucleotide and nucleoside analogues, renal toxicity is uncommon in telbivudine, and dosage adjustment is not required in patients with mild renal impairment. We propose to conduct an open-label single-arm study to evaluate the effect of telbivudine on renal function and proteinuria in patients with chronic HBV infection and mild-to-moderate renal impairment. Twenty patients with chronic HBV infection and chronic kidney disease (estimated glomerular filtration rate 15 to 60 ml/min) will be recruited. They will be treated with telbivudine, with the dosage adjusted according to thei renal function, for 5 years. Serum HBV DNA, proteinuria, renal function, and urinary inflammatory markers will be monitored.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- change in estimated glomerular filtration rate [ Time Frame: every 3 months for 5 years ] [ Designated as safety issue: No ]
- proteinuria [ Time Frame: every 3 months for 5 years ] [ Designated as safety issue: No ]
- HBV DNA level [ Time Frame: every 6 months for 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Chronic kidney disease (CKD) is a major public health problem worldwide over the past few decades, partly because of the increasing prevalence of hypertension, diabetes mellitus, and elderly individuals in most countries. In southeast Asia, chronic viral hepatitis due to hepatitis B virus (HBV) also poses significant morbidity and mortality . Chronic HBV infection can cause chronic glomerulonephritis and CKD. More importantly, patients with CKD, irrespective to the underlying renal diagnosis, who acquire HBV infection have higher morbidity and mortality rates, and the management of chronic HBV infections among CKD patients with antiviral agents is associated with a high risk of adverse effects. The optimal management of CKD associated with chronic HBV infection is not well defined because of insufficient data from clinical trials.
Telbivudine (Sebivo®; Tyzeka®) is a synthetic nucleoside analogue that inhibits replication of HBV. Telbivudine is a potent antiviral that provides effective and sustained viral suppression in patients with compensated chronic hepatitis B infection, and is used in the treatment of adults with chronic hepatitis B with evidence of viral replication and persistently elevated serum transaminase levels, or histological evidence of active disease. Unlike most of the other nucleoside and nucleotide analogues, renal toxicity of telbivudine is uncommon, and dose adjustment is only necessary for patients with moderate to severe renal impairment. Recent data further suggest that telbivudine treatment may have a beneficial effect on renal function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02049736
|Contact: Henry LY Chan, MD||(852)firstname.lastname@example.org|
|Contact: Angel ML Chim, MD||(852)email@example.com|
|Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital||Not yet recruiting|
|Hong Kong, Hong Kong|
|Contact: Henry LY Chan, MD (852)2632-2211 firstname.lastname@example.org|
|Contact: Angel ML Chim, MSc (852)2632 4205 email@example.com|
|Sub-Investigator: Vincent WS Wong, MD|
|Sub-Investigator: Grace LH Wong, MD|