- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049736
Effect of Telbivudine on Renal Function and Proteinuria in Patients With CHB & Chronic Renal Diseases
The Effect of Telbivudine on Renal Function and Proteinuria in Patients With Chronic Hepatitis B Infection and Chronic Kidney Diseases
Study Overview
Detailed Description
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 [2]. 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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telbivudine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in estimated glomerular filtration rate
Time Frame: every 3 months for 5 years
|
every 3 months for 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
proteinuria
Time Frame: every 3 months for 5 years
|
every 3 months for 5 years
|
HBV DNA level
Time Frame: every 6 months for 5 years
|
every 6 months for 5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.
- Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24.
- Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.
- Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, Chen Y, Heathcote EJ, Rasenack J, Bzowej N, Naoumov NV, Di Bisceglie AM, Zeuzem S, Moon YM, Goodman Z, Chao G, Constance BF, Brown NA; Globe Study Group. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007 Dec 20;357(25):2576-88. doi: 10.1056/NEJMoa066422.
- Chen J, Wildman RP, Gu D, Kusek JW, Spruill M, Reynolds K, Liu D, Hamm LL, Whelton PK, He J. Prevalence of decreased kidney function in Chinese adults aged 35 to 74 years. Kidney Int. 2005 Dec;68(6):2837-45. doi: 10.1111/j.1523-1755.2005.00757.x.
- Bhimma R, Coovadia HM. Hepatitis B virus-associated nephropathy. Am J Nephrol. 2004 Mar-Apr;24(2):198-211. doi: 10.1159/000077065. Epub 2004 Feb 25.
- Chacko EC, Surrun SK, Mubarack Sani TP, Pappachan JM. Chronic viral hepatitis and chronic kidney disease. Postgrad Med J. 2010 Aug;86(1018):486-92. doi: 10.1136/pgmj.2009.092775.
- Wong PN, Fung TT, Mak SK, Lo KY, Tong GM, Wong Y, Loo CK, Lam EK, Wong AK. Hepatitis B virus infection in dialysis patients. J Gastroenterol Hepatol. 2005 Nov;20(11):1641-51. doi: 10.1111/j.1440-1746.2005.03837.x.
- London WT, Drew JS, Lustbader ED, Werner BG, Blumberg BS. Host responses to hepatitis B infection in patients in a chronic hemodialysis unit. Kidney Int. 1977 Jul;12(1):51-8. doi: 10.1038/ki.1977.78.
- Peters MG. Special populations with hepatitis B virus infection. Hepatology. 2009 May;49(5 Suppl):S146-55. doi: 10.1002/hep.22965.
- Girndt M, Kohler H. Hepatitis B virus infection in hemodialysis patients. Semin Nephrol. 2002 Jul;22(4):340-50.
- Fabrizi F, Messa P, Basile C, Martin P. Hepatic disorders in chronic kidney disease. Nat Rev Nephrol. 2010 Jul;6(7):395-403. doi: 10.1038/nrneph.2010.37. Epub 2010 Apr 13.
- McKeage K, Keam SJ. Telbivudine: a review of its use in compensated chronic hepatitis B. Drugs. 2010 Oct 1;70(14):1857-83. doi: 10.2165/11204330-000000000-00000.
- But DY, Yuen MF, Fung J, Lai CL. Safety evaluation of telbivudine. Expert Opin Drug Saf. 2010 Sep;9(5):821-9. doi: 10.1517/14740338.2010.507190.
- Zhou XJ, Swan S, Smith WB, Marbury TC, Dubuc-Patrick G, Chao GC, Brown NA. Pharmacokinetics of telbivudine in subjects with various degrees of renal impairment. Antimicrob Agents Chemother. 2007 Dec;51(12):4231-5. doi: 10.1128/AAC.00557-07. Epub 2007 Sep 17.
- Gane EJ, Wang Y, Liaw YF, Hou J, Thongsawat S, Wan M, Moon YM, Jia J, Chao YC, Niu J, Leung N, Samuel D, Hsu CW, Bao W, Lopez P, Avila C. Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B. Liver Int. 2011 May;31(5):676-84. doi: 10.1111/j.1478-3231.2011.02490.x. Epub 2011 Mar 16.
- Szeto CC, Chow KM, Kwan BC, Chung KY, Leung CB, Li PK. Oral calcitriol for the treatment of persistent proteinuria in immunoglobulin A nephropathy: an uncontrolled trial. Am J Kidney Dis. 2008 May;51(5):724-31. doi: 10.1053/j.ajkd.2007.12.038. Epub 2008 Apr 3.
- Grubb A, Nyman U, Bjork J, Lindstrom V, Rippe B, Sterner G, Christensson A. Simple cystatin C-based prediction equations for glomerular filtration rate compared with the modification of diet in renal disease prediction equation for adults and the Schwartz and the Counahan-Barratt prediction equations for children. Clin Chem. 2005 Aug;51(8):1420-31. doi: 10.1373/clinchem.2005.051557. Epub 2005 Jun 16.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Urologic Diseases
- Urological Manifestations
- Liver Diseases
- Urination Disorders
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis B
- Hepatitis
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Proteinuria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Telbivudine
Other Study ID Numbers
- Telbivudine for CKD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
Clinical Trials on Telbivudine
-
Nanfang Hospital of Southern Medical UniversityNovartis; Major Science and Technology Special Project of China Eleventh Five-yearUnknown
-
Novartis PharmaceuticalsCompletedAn Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis BChronic Hepatitis BKorea, Republic of
-
Chang Gung Memorial HospitalCompletedVirus Diseases | Disorder Related to Transplantation | Injury Due to Exposure to External Cause
-
Beijing Ditan HospitalUnknownImmune Globulin, Prophylaxis, Telbuvidine, Vaccine
-
Yonsei UniversityUnknownChronic Hepatitis BKorea, Republic of
-
Nanfang Hospital of Southern Medical UniversityNovartis; Major Science and Technology Special Project of China Eleventh Five-yearCompleted
-
Southeast University, ChinaCompletedChronic Hepatitis B | Pregnancy Complications | High Viral Load | Elevated Alanine Aminotransferase LevelsChina
-
Novartis PharmaceuticalsCompletedChronic Hepatitis BBelgium, Germany, United Kingdom, Philippines
-
NovartisNovartis PharmaceuticalsCompletedHepatitis BHong Kong, Singapore, New Zealand
-
Novartis PharmaceuticalsWithdrawnCompensated Chronic Hepatitis BUnited States, Puerto Rico