A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-14005366
• Date of registration: 2014-01-10
• Prospective Registration: Yes
• Primary sponsor: Department of Nephrology, China-Japan Friendship Hospital
• Public title: A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy
• Scientific title: A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy
• Date of first enrolment: 2014-09-01
• Target sample size: Low-dose hormone plus cyclophosphamide (CTX) grou:20;hormone+CsA:20;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=9713
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Contacts

• Name: Wenge Li

• Name: Li Zhuo
• Affiliation: Department of Nephrology, China-Japan Friendship Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Intends to select 40 cases of nephrotic syndrome, aged 18-70 years old, in Nephrology department in China-Japan Friendship Hospital between September 2014 to March 2015. Two groups, and each group has 20 cases. All the patients are nephrotic syndrome (which diagnostic criteria is 24 hours urinary protein more than 3.5g/d, serum albumin less than 30g/L), however, the serum creatinine less than 132.6umol/L (1.5mg/dl), and confirmed atypical membranous nephropathy by renal biopsy. The patients are Initial treatment, and there are not statistically significant difference in age and gender(P more than 0.05) and both are comparable.
Exclusion criteria: 1. seropositive hepatitis B and hepatitis C virus associated glomerulonephritis (HBV DNA and HCV RNA viral replication prompt), lupus nephritis, thyroid and other parts of the tumor, organic solvents, heavy metal poisoning, such as the film clearly secondary to secondary causes nephropathy; 2. serious infection or central nervous system symptoms; 3. abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than two times the upper limit of normal; 4. cardiac insufficiency; 5. abnormal glucose metabolism: fasting glucose more than 6.1 mmol/L or postprandial blood glucose more than 7.8 mmol/L; 6. pregnant or lactating women; 7. white blood cell count more than 3.0*10^9/L, platelet count less than 50*10^9/L; 8. The patients have mental illness and poor compliance.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Atypical membranous nephropathy

Intervention(s)

Low-dose hormone plus cyclophosphamide (CTX) grou:hormone, cyclophosphamide, three months;hormone+CsA:hormone+CsA, three months;

Primary Outcome(s)

24-h protein excretion;

Secondary Outcome(s)

urinalysis;Blood analysis;blood urea nitrogen;serum creatinine;ALT;AST;

Source(s) of Monetary Support

No