Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466801
Recruitment Status : Unknown
Verified March 2018 by Wenhu Liu, Beijing Friendship Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Wenhu Liu, Beijing Friendship Hospital

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
Idiopathic Membranous Nephropathy Drug: Prednisone Drug: MP and CTX Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 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.
Estimated Study Start Date : March 20, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : June 30, 2019


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 Name: 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 Name: Glucocorticoid and immunosuppressive agents




Primary Outcome Measures :
  1. nephrotic syndrome remission ( including complete remission and partial remission) [ Time Frame: 12 months ]
    nephrotic syndrome remission ( including complete remission and partial remission)


Secondary Outcome Measures :
  1. blood albumin≥30g/L [ Time Frame: 12 months ]
    blood albumin≥30g/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466801


Contacts
Layout table for location contacts
Contact: Zongli Diao, master +86-01-63138579 diaoted@163.com

Sponsors and Collaborators
Wenhu Liu
Investigators
Layout table for investigator information
Study Chair: Wenhu Liu, doctor Beijing Friendship Hospital
Study Director: Zongli Diao Beijing Friendship Hospital
Layout table for additonal information
Responsible Party: Wenhu Liu, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03466801    
Other Study ID Numbers: 2017-P2-172-02
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenhu Liu, Beijing Friendship Hospital:
prednisone alone
methylprednisolone and cyclophosphamide
membranous nephropathy in stage I
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Prednisone
Glucocorticoids
Immunosuppressive Agents
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors