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
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Membranous Nephropathy||Drug: Prednisone Drug: MP and CTX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- nephrotic syndrome remission ( including complete remission and partial remission) [ Time Frame: 12 months ]nephrotic syndrome remission ( including complete remission and partial remission)
- blood albumin≥30g/L [ Time Frame: 12 months ]blood albumin≥30g/L
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
|Contact: Zongli Diao, email@example.com|
|Study Chair:||Wenhu Liu, doctor||Beijing Friendship Hospital|
|Study Director:||Zongli Diao||Beijing Friendship Hospital|