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• Status: Withdrawn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: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Telbivudine

Criteria

Inclusion Criteria:

• aged 18-70 years

• hepatitis B surface antigen (HBsAg) positive

• clinical indication for antiviral therapy according to the Asian Pacific guideline [16]

• HBeAg positive, ALT >2 times upper limit of normal AND HBV DNA >20,000 IU/ml AND HBV DNA <9 log10 copies/mL; OR

• HBeAg negative, ALT >2 times upper limit of normal AND HBV DNA >2,000 IU/ml AND HBV DNA <7 log10 copies/mL; OR

• Evidence of advanced liver fibrosis or liver cirrhosis AND detectable HBV DNA

• estimated glomerular filtration rate (GFR) 15 to 60 ml/min/1.73m2

• willingness to give written consent and comply with the study protocol

Exclusion Criteria:

• Pregnancy, lactating or childbearing potential without effective method of birth control

• Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication

• History of malignancy, including leukemia and lymphoma within the past 2 years

• Active systemic infection.

• Any other severe coexisting disease such as, but not limited to, advanced liver cirrhosis, myocardial infarction, cerebrovascular accident, malignant hypertension

• History of drug or alcohol abuse within past 2 years

• Patients receiving antiviral therapy for chronic hepatitis B within the past 12 months

• Patients receiving treatment of corticosteroid or other immunosuppressive / cytotoxic agents

• On other investigational drugs within last 3 months

• History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study

• History of non-compliance

• Known history of sensitivity or allergy to telbivudine