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 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,600

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach

1 country

88 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

August 30, 2014

Completed

2 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

August 30, 2014

Last Update Submit

July 4, 2016

Conditions

IgA Nephropathy

Keywords

Abelmoschus manihotIgA Nephropathyproteinuriaefficacysafety

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (2)

Abelmoschus manihot (AM)

EXPERIMENTAL

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

Losartan

EXPERIMENTAL

Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.

Drug: Losartan

Interventions

LosartanDRUG

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.

Also known as: Cozaar

Losartan

Abelmoschus manihotDRUG

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.

Also known as: Huangkui Capsule

Abelmoschus manihot (AM)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
hour proteinuria ranged between 0.5g-3.0g
Obtaining the signed informed consent from patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chen Xiangmeilead
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.collaborator

Study Sites (88)

The First Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

COMPLETED

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

COMPLETED

Beijing Chao-yang Hospital