Clinical trial NCT02712697: Integrative Medicine of IgA Nephropathy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary IgA Nephropathy
Keywords: liver-kidney yin deficiency syndrome
primary severe IgA nephropathy
Lee's grade Ⅲ
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Ruijin Hospital
name: Shanghai 6th People's Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Fudan University
First posted: 2016-03-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
Secondary outcomes:
measure: 24-hour urinary protein excretion
timeFrame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
measure: serum creatinine
timeFrame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
measure: serum Lipid
timeFrame: Half-yearly
measure: TCM syndrome score
timeFrame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology,Longhua Hospital
Study officials:
References: