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Integrative Medicine of IgA Nephropathy

Primary Purpose

Primary IgA Nephropathy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

WM (Shentong Granules)

Hormone (prednisone)

About this trial

This is an interventional treatment trial for Primary IgA Nephropathy focused on measuring liver-kidney yin deficiency syndrome, primary severe IgA nephropathy, Lee's grade Ⅲ

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
TCM is liver kidney yin deficiency syndrome;
age 18-70 years old, sex, nationality is not limited;
CKD phase 2-4 （89 ml/min>eGFR（EPI Formula）>15ml/min/1.73m2）;
24 hour urinary protein≥1g.

Exclusion Criteria:

It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
Acute or progressive glomerulonephritis patients;
Severe complications threat to life, such as severe infection;
Active hepatitis B and liver function test sustained abnormal;
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;
Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
Gravid or lactation woman;
Other clinical trials are being studied;
Merger with other serious disease and dysfunction of the organ.

Sites / Locations

Department of Nephrology,Longhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

WM Group

Hormone Group

Arm Description

Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months

Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months

Outcomes

Primary Outcome Measures

Glomerular filtration rate

Secondary Outcome Measures

24-hour urinary protein excretion

serum creatinine

serum Lipid

TCM syndrome score

Full Information

NCT ID

NCT02712697

First Posted

November 17, 2015

Last Updated

March 17, 2016

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

RenJi Hospital, Ruijin Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02712697

Brief Title

Integrative Medicine of IgA Nephropathy

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

RenJi Hospital, Ruijin Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary IgA Nephropathy

Keywords

liver-kidney yin deficiency syndrome, primary severe IgA nephropathy, Lee's grade Ⅲ

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WM Group

Arm Type

Experimental

Arm Description

Arm Title

Hormone Group

Arm Type

Placebo Comparator

Arm Description

Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months

Intervention Type

Drug

Intervention Name(s)

WM (Shentong Granules)

Other Intervention Name(s)

Shentong Granules

Intervention Description

Shentong Granules with Prednisone

Intervention Type

Drug

Intervention Name(s)

Hormone (prednisone)

Other Intervention Name(s)

prednisone

Intervention Description

Oral prednisone

Primary Outcome Measure Information:

Title

Glomerular filtration rate

Time Frame

changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Secondary Outcome Measure Information:

Title

24-hour urinary protein excretion

Time Frame

changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Title

serum creatinine

Time Frame

changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

Title

serum Lipid

Time Frame

Half-yearly

Title

TCM syndrome score

Time Frame

changes from Baseline to 2, 4, 12, 24,36 and 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above; TCM is liver kidney yin deficiency syndrome; age 18-70 years old, sex, nationality is not limited; CKD phase 2-4 （89 ml/min>eGFR（EPI Formula）>15ml/min/1.73m2）; 24 hour urinary protein≥1g. Exclusion Criteria: It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks; It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks; Acute or progressive glomerulonephritis patients; Severe complications threat to life, such as severe infection; Active hepatitis B and liver function test sustained abnormal; 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; Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L; Gravid or lactation woman; Other clinical trials are being studied; Merger with other serious disease and dysfunction of the organ.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yueyi Deng, MD.

Phone

+86-021-64385700-3226

dengyueyi@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wanjia Chen, MS.

Phone

+86-021-64385700-3222

wdgzkj@sina.com

Facility Information:

Facility Name

Department of Nephrology,Longhua Hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YueYI Deng, Dr.

Phone

64385700

Ext

3222

lhkidney@hotmail.com

12. IPD Sharing Statement

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Integrative Medicine of IgA Nephropathy

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