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Trial record 156 of 350 for:    hepatitis b | Open Studies

Tacrolimus Combined With Entecavir on HBV Associated Glomerulonephritis(HBV-GN) (TOHBVGN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Guangdong General Hospital
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT03062813
First received: February 20, 2017
Last updated: February 22, 2017
Last verified: February 2017
  Purpose
This study was to evaluate the efficacy and safety of Tacrolimus combined with entecavir antiviral therapy for HBV-associated glomerulonephritis in china. Tacrolimus combined with entecavir rapidly and effectively induced remission of HBV-GN in Chinese adults. Meanwhile, Tacrolimus may have a synergistic antiviral effect with entecavir. The study protocol was reviewed and approved by Guangdong General Hospital's Ethic Committee, and all participants provided written informed consents. The study will be a prospective, randomized,controlled,single-blind, multi-centre, withdrawal study conducted by Guangdong general hospital, Guangdong Academy of Medical Sciences.there will be two phases, phase 1, Screening and enrolling 112 HBV-GN patients about one year,and phase 2, ongoing follow-up for 24 weeks.The data of all patients will be recorded in the HBV-GN electronic database.Before the randomisation, All patients will receive entecavir routine antiviral therapy for two weeks.And then they will be randomized to two different group,the treatment group: Tacrolimus combined with entecavir antiviral therapy,the control group: The Tacrolimus placebo and entecavir antiviral therapy. The Tacrolimus target trough concentration was 5-10 ng/mL during the therapy. The primary outcome variables were the number of patients who reached complete or partial remission (CR or PR) after the 25 week-treatment. CR was defined as <0.3 g/24 h proteinuria (UPCR<300mg/g.cr) or lower plus stable renal function (eGFR>50 ml/min/1.73 m2) and PR as proteinuria 0.3-3.0 g/24 h (UPCR 300-3000mg/g.cr) and 50% lower than baseline proteinuria plus stable renal function. Secondary outcome variables: 1) The number of patients who reached complete or partial remission (CR or PR) after the 13 week-treatment. 2) Serum creatinine (SCr) increased 2 times the baseline levels or 50% lower than the baseline eGFR(according to chronic kidney disease-EPI (CKD-EPI) )after the 25 week-treatment. 3)Serum HBV DNA was undetectable(HBV DNA<500copies/ml) at the end of 25 week-treatment. 4) The number of patients who present acute kidney injury at the end of 25 week-treatment.

Condition Intervention Phase
Hepatitis B Virus Associated Nephrotic Syndrome
Drug: Tacrolimus &entecavir
Drug: placebo & entecavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: The Therapy of Tacrolimus Combined With Entecavir on HBV Associated Glomerulonephritis : A Multicenter, Prospective, Randomized, Controlled, Single-blind Trial.

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • Remission rate of proteinuria [ Time Frame: 25 weeks ]
    the number of patients who reached complete or partial remission (CR or PR) after the 25 week-treatment. CR was defined as <0.3 g/24 h proteinuria (UPCR<300mg/g.cr) or lower plus stable renal function (eGFR>50 ml/min/1.73 m2) and PR as proteinuria 0.3-3.0 g/24 h (UPCR 300-3000mg/g.cr) and 50% lower than baseline proteinuria plus stable renal function.


Secondary Outcome Measures:
  • Remission rate of proteinuria [ Time Frame: 13 weeks ]
    The number of patients who reached complete or partial remission (CR or PR) after the 13 week-treatment.

  • The change of Scr [ Time Frame: 25 weeks ]
    SCr increased 2 times the baseline levels or 50% lower than the baseline eGFR(according to CKD-EPI)

  • Serum HBV DNA [ Time Frame: 25 weeks ]
    Serum HBV DNA was undetectable(HBV DNA<500copies/ml) at the end of 25 week-treatment.

  • The rate of acute kidney injury [ Time Frame: 25 weeks ]
    The number of patients who present acute kidney injury at the end of 25 week-treatment.


Estimated Enrollment: 112
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: March 31, 2020
Estimated Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus & entecavir
Tacrolimus capsule, 0.5mg/capsule,1.0mg/capsule, 0.05-0.1mg/kg.d by mouth , every 12 hours for a day.Entecavir 0.5mg tablet by mouth every night.
Drug: Tacrolimus &entecavir
HBV-GN patients with nephrotic syndrome were randomly givenTacrolimus (0.05-0.1 mg/kg/day) combined with entecavir. Tacrolimus was divided into two daily doses at 12-hour intervals. Subsequent doses were adjusted to achieve a whole blood 12-hour trough level between 5 and 10 ng/ml.All patients will receive entecavir antiviral therapy(0.5mg/d), entecavir was taken once a day. All of HBV-GN patients were followed up to 25week.
Other Name: FK506,Prograf, baraclude
Active Comparator: placebo & entecavir
Tacrolimus capsule, 0.5mg/capsule,1.0mg/capsule, 0.05-0.1mg/kg.d by mouth , every 12 hours for a day.Entecavir 0.5mg tablet by mouth every night.
Drug: placebo & entecavir
HBV-GN patients with nephrotic syndrome were randomly givenTacrolimus placebo (0.05-0.1 mg/kg/day) combined with entecavir.Tacrolimus placebo was divided into two daily doses at 12-hour intervals. All patients will receive entecavir antiviral therapy(0.5mg/d), entecavir was taken once a day. All of HBV-GN patients were followed up to 25week.
Other Name: baraclude

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients aged between 18 and 65 years with HBV-GN;
  • All HBV-GN cases with biopsy-proven;
  • Evidence of chronic HBV infection based on the presence of HBsAg, HBeAg or HBV DNA in the serum;(HBsAg, HBeAg was positive, HBV DNA ≥10*3 IU/ml). Chronic HBV infection lasted for six months, and all patients did not receive the antiviral therapy in the past six months;
  • Proteinuria more than 3.0g/24h, UPCR>3000mg/g.cr, the result will be proofed by at least two tests;
  • No glucocorticoid and immunosuppressive treatment within the previous 2 weeks.

Exclusion Criteria:

  • The diagnosis of idiopathic membranous nephropathy(MN), systemic lupus erythematosus, malignancy, diabetes mellitus, severe infections or any other systemic disease known to be associated with secondary MN;
  • eGFR<30ml/min.1.73m*2;
  • Renal pathology showed that Tubular atrophy or Interstitial fibrosis was more than 50%;
  • The participant is allergy to tacrolimus, entecavir;
  • History of diabetes mellitus;
  • History of severe heart disease or cerebrovascular diseases;
  • Other active infection such as cytomegalovirus (CMV),Tuberculosis,Hepatitis A virus (HAV),Hepatitis C virus (HCV),Hepatitis D virus (HDV); Innate or acquired immunodeficiency; liver cirrhosis, liver malignment tumor;
  • Pregnant, trying to become pregnant or breast feeding;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03062813

Contacts
Contact: Zhiming Ye, PHD 86-13826161678 13826161678@139.com
Contact: Lifen Wang, PHD 86-18022392896 15010942109@139.com

Locations
China, Guangdong
Guangdong General Hospital, Guangdong Academy of Medical Sciences Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Liming Yao, bachelor    86-83827812-20894      
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Study Chair: Zhiming Ye, PHD Guangdong General Hospital, Guangdong Academy of Medical Sciences
Principal Investigator: Lifen Wang, PHD Guangdong General Hospital, Guangdong Academy of Medical Sciences
Principal Investigator: Lixia Xu, PHD Guangdong General Hospital, Guangdong Academy of Medical Sciences
Principal Investigator: Xinling Liang, PHD Guangdong General Hospital, Guangdong Academy of Medical Sciences
Study Director: Wei Shi, PHD Guangdong General Hospital, Guangdong Academy of Medical Sciences
  More Information

Publications:

Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT03062813     History of Changes
Other Study ID Numbers: ZMYe
Study First Received: February 20, 2017
Last Updated: February 22, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Guangdong General Hospital:
Hepatitis B virus, tacrolimus,membranous nephropathy

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Nephrotic Syndrome
Nephrosis
Glomerulonephritis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Kidney Diseases
Urologic Diseases
Nephritis
Tacrolimus
Entecavir
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 24, 2017