The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03466801
• Other study ID #: 2017-P2-172-02
• Status: Terminated
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage I membranous nephropathy.

Description:

Idiopathic membranous nephropathy (IMN) is one of the most common cause of adult nephrotic syndrome. Prednisolone and methylprednisolone are essential drugs for IMN. However, there are no recommendations for the treatment of IMN in China. KDIGO guidelines recommend combination therapy with methylprednisolone and cyclophosphamide as first-line therapy of IMN, but there is a large side effect of cyclophosphamide.There were retrospective study showed that the use of glucocorticoid hormones (including prednisone and methylprednisolone) alone may be effective in patients with membranous nephropathy in Asia, but there is no high quality evidence of evidence-based medicine.The study is a randomized prospective controlled multi-centered trial,to compare the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of membranous nephropathy in stage I.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy

2. Meeting one of the following three condition:

• Urine protein quantitation >4g/d,or 50% higher than baseline,RASS blocker treat for 6 months without trend of decrease ?Serious or disabling complications related to nephrotic syndrome ?In the 6-12 months after diagnosis of idiopathic membranous nephropathy, serum creatinine increased by more than 30%, while eGFR eGFR=25ml/min/1.73m2.And excludeing other causes of renal dysfunction

Exclusion Criteria:

1. Secondary membranous nephropathy

2. Serious complications

3. Considering the effect of cyclophosphamide on the of function of sex gland,all patients with childbearing age or fertility requirement cannot participate in this study

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• Prednisone
Prednisone was taken for oral administration with dosage of 1mg/kg/d (maximum 60mg/d) by 8 weeks to start.Then reduced Gradually until the end of the experiment.
• MP and CTX
Methylprednisolone(MP) was injected for 3 day(if weight >60kg ,500mg/d<60kg,300mg/d ), methylprednisolone was 0.4mg/kg/d for 27 day.Cyclophosphamide(CTX) orally was 100mg/ d for 1 month.And repeated for six months.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Wenhu Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nephrotic syndrome remission ( including complete remission and partial remission)	nephrotic syndrome remission ( including complete remission and partial remission)	12 months
Secondary	blood albumin=30g/L	blood albumin=30g/L	12 months