Status:
UNKNOWN
Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy
Lead Sponsor:
Chen Xiangmei
Collaborating Sponsors:
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely use...
Detailed Description
The test has not been completed .
Eligibility Criteria
Inclusion
- Clinical diagnosed as chronic nephritic syndrome
- IgA nephropathy diagnosed by kidney biopsy
- Aged from 18 to 65 years，male or female
- Blood pressure of ≤140/90mmHg
- Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2
- 24-hour proteinuria ranged between 0.5g-3.0g
- Obtaining the signed informed consent from patients
Exclusion
- Secondary IgA nephropathy
- Be allergic to Huangkui Capsule or Losartan potassium tablet
- Taken Huangkui Capsule or ACEI or ARB in last 6 weeks
- Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as drugs with immunosuppressive actions in the last 12 months
- Blood pressure \<90/60mmHg
- Serum potassium level \> 5.5mmol / L
- Serum albumin level \<30g / L
- Lactation, pregnancy or plans pregnancy during the study period
- Unilateral or bilateral renal artery stenosis
- Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
- Participating in another clinical study in the same period
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT02231125
Start Date
September 1 2014
End Date
December 1 2017
Last Update
July 6 2016
Active Locations (88)
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1
The First Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
3
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, China, 100000
4
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100000