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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02712697
Other study ID # ZY3- CCCX-2-1002
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 17, 2015
Last updated March 17, 2016
Start date June 2016
Est. completion date December 2017

Study information

Verified date November 2015
Source Shanghai University of Traditional Chinese Medicine
Contact Yueyi Deng, MD.
Phone +86-021-64385700-3226
Email dengyueyi@medmail.com.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.


Description:

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;

2. TCM is liver kidney yin deficiency syndrome;

3. age 18-70 years old, sex, nationality is not limited;

4. CKD phase 2-4 (89 ml/min>eGFR(EPI Formula)>15ml/min/1.73m2);

5. 24 hour urinary protein=1g.

Exclusion Criteria:

1. It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;

2. It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;

3. Acute or progressive glomerulonephritis patients;

4. Severe complications threat to life, such as severe infection;

5. Active hepatitis B and liver function test sustained abnormal;

6. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;

7. Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;

8. Gravid or lactation woman;

9. Other clinical trials are being studied;

10. Merger with other serious disease and dysfunction of the organ.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
WM (Shentong Granules)
Shentong Granules with Prednisone
Hormone (prednisone)
Oral prednisone

Locations

Country Name City State
China Department of Nephrology,Longhua Hospital Shanghai

Sponsors (6)

Lead Sponsor Collaborator
Shanghai University of Traditional Chinese Medicine Fudan University, RenJi Hospital, Ruijin Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glomerular filtration rate changes from Baseline to 2, 4, 12, 24,36 and 48 weeks No
Secondary 24-hour urinary protein excretion changes from Baseline to 2, 4, 12, 24,36 and 48 weeks No
Secondary serum creatinine changes from Baseline to 2, 4, 12, 24,36 and 48 weeks No
Secondary serum Lipid Half-yearly No
Secondary TCM syndrome score changes from Baseline to 2, 4, 12, 24,36 and 48 weeks No
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