Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2016
• Main ID: NCT02231125
• Date of registration: 30/08/2014
• Prospective Registration: Yes
• Primary sponsor: Chen Xiangmei
• Public title: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy
• Scientific title: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial
• Date of first enrolment: September 2014
• Target sample size: 1600
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02231125
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Xiangmei Chen, MD.& Ph.D
• Affiliation: Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital

• Name: Xiangmei Chen, MD.&Ph.D

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Abelmoschus manihot

Drug: Losartan

Primary Outcome(s)

Change in 24-h proteinuria from baseline after treatment [Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48]

Secondary Outcome(s)

Change in estimated glomerular filtration rate (eGFR) from baseline after treatment [Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48]

Change in serum creatinine from baseline after treatment [Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48]

Secondary ID(s)

S2014-039-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jiangsu Suzhong Pharmaceutical Group Co., Ltd.