Clinical trial for corticosteroids monotherapy in the treatment of seronegative hepatitis B virus-associated membranous nephropathy.

• Register: ChiCTR
• Last refreshed on: 23 April 2019
• Main ID: ChiCTR1900022518
• Date of registration: 2019-04-15
• Prospective Registration: No
• Primary sponsor: Tianjin Hospital
• Public title: Clinical trial for corticosteroids monotherapy in the treatment of seronegative hepatitis B virus-associated membranous nephropathy.
• Scientific title: Efficacy and safety of corticosteroids in 26 cases of seronegative hepatitis B virus-associated membranous nephropathy
• Date of first enrolment: 2004-04-01
• Target sample size: Case series:26;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=38023
• Study type: Observational study
• Study design: Single arm
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Sha Chen
• Affiliation: Tianjin Medical University

• Name: Dingwei Yang
• Affiliation: Tianjin Hospital

Key inclusion & exclusion criteria

Inclusion criteria: (1) The presence of profound proteinuria >3.5 g/d and a serum albumin level <30 g/L with or without edema or hyperlipidemia;
(2) Pathological diagnosis of renal biopsy was HBV-associated membranous nephropathy;
(3) The absence of HBsAg, HBeAg, HBcAg and HBV-DNA replication in the serum;
(4) No immunosuppressive agents, corticosteroids were allowed in the 3 months prior to the entry of the study;
(5) Patients with normal renal function;
(6) Male and female aged 18-80 years old;
(7) Patients and their families signed the informed consent.
Exclusion criteria: (1) Evidence of HBV antigen or HBV DNA in the serum;
(2) Idiopathic membranous nephropathy and secondary membranous nephropathy except hepatitis B virus-associated membranous nephropathy;
(3) Patients who does not meet the criterion of nephrotic syndrome;
(4) Renal insufficiency with Scr>1.3mg/dl(115umol/L) at the beginning of treatment;
(5) Patients with other diseases with an expected survival period of less than 2 years, such as tumors, AIDS and severe infections that cannot be controlled;
(6) Plasma exchange, immunosuppressive agents, corticosteroids, CTX and other cytotoxic drugs were performed in the 3 months prior to the entry of the study;
(7) Pregnant or lactating patients;
(8) Patients with mental disorders or incapacitated patients;
(9) Poor drug compliance;
(10) Patients who can not promise to have a regular follow-up.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Seronegative Hepatitis B Virus-associated Membranous Nephropathy

Intervention(s)

Case series:give corticosteroids(Methylprednisolone);

Primary Outcome(s)

24 hours urinary protein quantity;Serum albumin;Serum creatinine;

Secondary Outcome(s)

Blood urea nitrogen;Uric acid;Triglyceride;Cholesterin;

Source(s) of Monetary Support

the National Natural Science Fundation of China (81670631) and the Tianjin Natural Science Foundation (16JCYBJC25600)

Ethics review

Status: Approved
Approval date: 08/04/2019
Contact:

Shilian Kan