Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

Study Overview
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Brief Summary
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-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 used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.

Detailed Description
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The test has not been completed .

Official Title
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Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Losartan
* Drug: Abelmoschus manihot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abelmoschus manihot (AM)<br>Abelmoschus manihot (AM): Huangkui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot. | Drug: Abelmoschus manihot<br>* Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.<br>* Other names: Huangkui Capsule;|
| Experimental: Losartan<br>Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box. | Drug: Losartan<br>* Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.<br>* Other names: Cozaar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-h proteinuria from baseline after treatment |  | Baseline(week 0), week 4, week 12, week 24, week 36, week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum creatinine from baseline after treatment |  | Baseline(week 0), week 4, week 12, week 24, week 36, week 48 | 
| Change in estimated glomerular filtration rate (eGFR) from baseline after treatment |  | Baseline(week 0), week 4, week 12, week 24, week 36, week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abelmoschus manihot, IgA Nephropathy, proteinuria, efficacy, safety