Integrative Medicine of IgA Nephropathy

Primary IgA Nephropathy Clinical Trial

Official title:

Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02712697
• Other study ID #: ZY3- CCCX-2-1002
• 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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Kidney Diseases
• Primary IgA Nephropathy

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