Clinical trial NCT02610595: Study on the Therapeutic Effect of TCM Treatment for MDR MN
Official title: A Prospective, Multi-center Study of the Chinese Medicine for the Treatment of MDR Membranous Nephropathy in the Traditional Chinese Medicine (a Herbal Formula for Invigorating Spleen and Benefiting qi and Promoting Blood Circulation)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Membranous Nephropathy
Keywords: Idiopathic Membranous Nephropathy
Jianpiyiqi Recipe
Huoxuejiedu Recipe
Effectiveness
Safety
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Ruijin Hospital
name: Shanghai 6th People's Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Changhai Hospital
name: Shanghai Putuo District Center Hospital
name: ShuGuang Hospital
name: Shanghai Yueyang Integrated Medicine Hospital
name: Shanghai Changzheng Hospital
name: Shanghai Minhang Central Hospital
name: Zhujiang Hospital
name: Guangxi Traditional Chinese Medical University
name: Huashan Hospital
name: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
name: Xinqiao Hospital of Chongqing
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Nanjing University of Traditional Chinese Medicine
name: Tongji Hospital
name: Chinese Academy of Sciences
name: RenJi Hospital
First posted: 2015-11-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.

Detailed description: Based on previous research, the investigators hoping to identity the standard treatment program for MDR IMN patients with high treatment difficulty, TCM syndrome of s Pixushuifan. Subsequently, to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. With twenty national-grade III hospital of to formed TCM Comprehensive treatment plan and to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. Furthermore, search for potential diagnostic predictor in IMN by Proteomics and Metabolomics. The investigators purpose is improve the clinical remission rate of MN, further establish the treatment of TCM in the treatment of MN.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years;
2. Gender, nationality;
3. Pixushuifan syndrome, IMN confirmed by renal biopsy and clinical examination;
4. Treatment invalided by two or more than two kinds of Hormone or immunosuppressive agents ;
5. CKD phase 1-3（eGFR（EPI Formula）≥30ml/min/1.73m2）

Exclusion Criteria:

1. Progressive MN (progressive renal impairment, renal biopsy confirmed Necrotic Vasculitis and Large crescent formation\>50%), combined with IgA nephropathy, diabetic nephropathy and other renal diseases;
2. Anti-nuclear antibodies, double stranded DNA, ANCA or other indicators of immune disorders;
3. Active hepatitis B and liver function test sustained abnormal;
4. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases;
5. Merger with other serious disease and dysfunction of the organ;
6. Gravid or lactation woman;
7. Other clinical trials are being studied.

Primary outcomes:
measure: Remission rate of 24 hours urinary protein quantitative
timeFrame: two weeks to three months
Secondary outcomes:
measure: Renal function, glomerular filtration rate (EPI formula), Plasma albumin
timeFrame: two weeks to three months
measure: Blood lipid
timeFrame: half a year
measure: Change of TCM Syndrome
timeFrame: two weeks to three months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology,Longhua Hospital
Study officials:
References: