Integrative Medicine of IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02712697
• Date of registration: 17/11/2015
• Prospective Registration: Yes
• Primary sponsor: Shanghai University of Traditional Chinese Medicine
• Public title: Integrative Medicine of IgA Nephropathy
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 140
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02712697
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Yueyi Deng, MD.

• Name: YueYI Deng, Dr.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary IgA Nephropathy

Intervention(s)

Drug: Hormone (prednisone)

Drug: WM (Shentong Granules)

Primary Outcome(s)

Glomerular filtration rate [Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks]

Secondary Outcome(s)

serum creatinine [Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks]

serum Lipid [Time Frame: Half-yearly]

24-hour urinary protein excretion [Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks]

TCM syndrome score [Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks]

Secondary ID(s)

ZY3- CCCX-2-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ruijin Hospital

RenJi Hospital

Shanghai 6th People's Hospital

Fudan University

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine