Effect of Telbivudine on Renal Function and Proteinuria in Patients With CHB & Chronic Renal Diseases
Status:
Withdrawn
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
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.