Integrative Medicine of IgA Nephropathy

Not Applicable

• Conditions: Primary IgA Nephropathy
• Interventions: Drug: WM (Shentong Granules); Drug: Hormone (prednisone)

• Registration Number: NCT02712697
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2015-11
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Study First Posted: 2016-03-18
• Last Update Posted: 2016-03-18
• Study Start: 2016-06
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WM Group	WM (Shentong Granules)	Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
Hormone Group	Hormone (prednisone)	Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
WM Group	Hormone (prednisone)	Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Secondary Outcome Measures

Name	Time	Method
TCM syndrome score	changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
24-hour urinary protein excretion	changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
serum Lipid	Half-yearly
serum creatinine	changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Trial Locations

Locations (1)

Department of Nephrology,Longhua Hospital; 🇨🇳 Shanghai, China