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

Sponsor
Wenhu Liu (Other)
Overall Status
Terminated
CT.gov ID
NCT03466801
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.
Actual Study Start Date :
Mar 20, 2018
Actual Primary Completion Date :
Jan 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Glucocorticoid
  • Active Comparator: 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.

    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.
    Other Names:
  • Glucocorticoid and immunosuppressive agents
  • Outcome Measures

    Primary Outcome Measures

    1. nephrotic syndrome remission ( including complete remission and partial remission) [12 months]

      nephrotic syndrome remission ( including complete remission and partial remission)

    Secondary Outcome Measures

    1. blood albumin≥30g/L [12 months]

      blood albumin≥30g/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Friendship Hospital, Capital Medical University Beijing China 100050

    Sponsors and Collaborators

    • Wenhu Liu

    Investigators

    • Study Chair: Wenhu Liu, doctor, Beijing Friendship Hospital
    • Study Director: Zongli Diao, Beijing Friendship Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wenhu Liu, Professor, Beijing Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT03466801
    Other Study ID Numbers:
    • 2017-P2-172-02
    First Posted:
    Mar 15, 2018
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wenhu Liu, Professor, Beijing Friendship Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022