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

NCT ID: NCT03466801

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2019-06-30

Brief 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.

Detailed 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.

Conditions

Idiopathic Membranous Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group prednisone

Prednisone was taken 1mg/kg/d(maximum 60mg/d)for 8 weeks to start.Then decreased 5mg every 2 weeks; When reduced to 40mg,reduced 5mg every 4 weeks. When reduced to 20mg, reduced 2.5mg every 8 weeks until the end.

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

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.

Group MP and CTX

The first month,Methylprednisolone(MP) was injected for 3 days(weight \>60kg,500mg/d;\<60 kg,300mg/d),and 0.4mg/kg/d for 27 day.The second month,Cyclophosphamide(CTX) orally was 100mg/d for 1 month.And this regimen is repeated for six months.

Group Type: ACTIVE_COMPARATOR

MP and CTX

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Glucocorticoid; Glucocorticoid and immunosuppressive agents

Eligibility Criteria

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 ②Serious or disabling complications related to nephrotic syndrome ③In 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenhu Liu

OTHER

Sponsor Role: lead

Responsible Party

Wenhu Liu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wenhu Liu, doctor

Role: STUDY_CHAIR

Beijing Friendship Hospital

Zongli Diao

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

2017-P2-172-02

Identifier Type: -

Identifier Source: org_study_id