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Optimal options of antiviral programs in CKD combined with chronic hepatitis B immunosuppressive treatment patients.

Optimal options of antiviral programs in CKD combined with chronic hepatitis B immunosuppressive treatment patients.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004454
Enrollment
Unknown
Registered
2013-09-09
Start date
2014-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease combined with Chronic Hepatitis B infection

Interventions

Telbivudine group:Telbivudine treatment
entecavir group:entecavir

Sponsors

Nephrology Department, the First Affiliated Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Males or females aged 16-70 years; 2. Nephrotic syndrome or primary glomerulonephritis combined with Hepatitis B virus infection; HBsAg positive; regardless of ALT, HBV-DNA status; 3. Nephrotic syndrome or primary glomerulonephritis combined with Hepatitis B virus infection Require a long course of Corticosteroids immunosuppression; 4. Serum creatinine less than 3mg/ml (265umol/L) or eGFR>30ml/min; 5. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits); participate in the study after the purpose and nature of the investigation has been clearly explained to them.

Exclusion criteria

Exclusion criteria: 1. Patients who has the severe heart, lung and hematopoietic system diseases; 2. Patients with cancer or other malignant diseases; 3. Pregnant or nursing; 4. Psychiosis, acrasia and unable to express himself explicitly; 5. Decompensated cirrhosis; 6. Serum creatinine more than 3mg/ml (265µmol/L) or eGFR<30ml/min; 7. Persons who are participating in other clinical trials; or Persons, in the opinion of investigator, are unsuitable to participate in the clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
vital sign;24h urinary protein;Hemoglobin (HGB);Red blood cells (RBC);white blood cells (WBC);Platelets (PLC);Neutrophils;Aspartate aminotransferase (AST);Alanine aminotransferase (ALT);Serum albumin (ALBm);Blood urea nitrogen (BUN);Serum creatinine (SCr);Serum uric acid (UA);Glucose (GLU);Triglycerides;Total cholesterol;estimated GFR;Lactate dehydrogenase (LDH);a-hydroxybutyrate dehydrogenase (a-HBDH);Creatine kinase (CK);Creatine kinase (CK-MB) activity;Hepatitis B surface antigen (HBsAg);Hepatitis B surface antibody (HBsAb);Hepatitis B e antigen (HBeAg);Hepatitis B e antibody (HBeAb);Hepatitis B core antibody (HBcAb);Hepatitis B core antibody IgM;HBV DNA quantification;HBV P region sequencing;Liver ultrasound;Renal ultrasoun;

Countries

China

Contacts

Public ContactZhao Hongwen

the First Affiliated Hospital, Third Military Medical University(Southwest Hospital)

zhaohongwen@medmail.com.cn+86 13983360655

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026