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

Efficacy and safety of corticosteroids in 26 cases of seronegative hepatitis B virus-associated membranous nephropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022518
Enrollment
Unknown
Registered
2019-04-15
Start date
2004-04-01
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Seronegative Hepatitis B Virus-associated Membranous Nephropathy

Interventions

Case series:give corticosteroids(Methylprednisolone)

Sponsors

Tianjin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Blood urea nitrogen;Uric acid;Triglyceride;Cholesterin;

Countries

China

Contacts

Public ContactDingwei Yang

Tianjin Hospital

dwyang2016@126.com+86 13512052807

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026