Integrative Medicine of IgA Nephropathy

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Primary IgA Nephropathy

Treatments: Drug: Hormone (prednisone); Drug: WM (Shentong Granules)

Study type: Interventional

Funder types: Other

Identifiers

NCT02712697

ZY3- CCCX-2-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

WM Group

Experimental group

Description:

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

Treatment:

Drug: WM (Shentong Granules)

Drug: Hormone (prednisone)

Hormone Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Hormone (prednisone)