Tubular Function in Asian-American Patients Receiving TDF or ETV for HBV Treatment
Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients. Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono infected Asian patients receiving TDF treatment.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Prospective and Open-Label Study of the Effect on Proximal Tubular Function in Asian-American Patients Receiving Tenofovir Disoproxil Fumarate (TDF) or Entecavir (ETV) for HBV Treatment|
- renal tubular dysfunction [ Time Frame: at 144 week after treatment with antiviral ] [ Designated as safety issue: Yes ]renal tubular dysfunction as determined by (1) 24 hours Urine phosphate (wasting is >1200 mg daily); (2) 24 hours β2-microglobulinuria (NL β2-microglobulin level, <1 mg daily); (3) fractional excretion of uric acid, and (4) fractional tubular reabsorption of phosphorus.
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Tenofovir Disoproxil Fumarate
Patients who are taking Tenofovir Disoproxil Fumarate.
Drug: Tenofovir Disoproxil Fumarate
300mg, oral daily for two years
Other Name: Viread
Patients who are taking Entecavir.
0.5mg oral daily for two years.
Other Name: Baraclude
The primary objective of this study is to evaluate the safety use of ETV and TDF after at least 144 weeks of treatment in terms of the effects of renal tubular function as determined by (1) 24 hours Urine phosphate (wasting is >1200 mg daily); (2) 24 hours β2-microglobulinuria (NL β2-microglobulin level, <1 mg daily); (3) fractional excretion of uric acid, and (4) fractional tubular reabsorption of phosphorus.
The secondary objectives are to evaluate:
- To evaluate compare the anti-viral effects of both TDF and ETV as determined the percentage of patient who achieve HBV DNA levels below 60 IU/mL (by quantitative HBV DNA PCR test with lowest level of detection at 60 IU/mL) and ALT normalization by routine biochemical test after 144 weeks of treatment.
- Serological responses including percentage of patients with HBeAg loss or seroconversion and HBsAg loss or seroconversion with TDF and ETV treatment in Asian-American adults with CHB infection.
- To evaluate the three-year (one year treatment before enrollment and two year treatment after enrollment) the percentage of patient with anti-HBV drug resistance of TDF and ETV, including genotypic mutations in Asian-American adults with CHB.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715987
|United States, California|
|Asian Pacific Liver Center at St. Vincent Medical Center|
|Los Angelos, California, United States, 90057|
|United States, New York|
|New Discovery LLC|
|New York, New York, United States, 11355|
|Principal Investigator:||Calvin Q Pan, M.D.||Mount Sinai School of Medicine, New York|