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A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

Primary Purpose

Glomerulonephritis, IGA, Peripapillary Crescent, Necrosis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Methylprednisolone(intravenously in the 1st-2nd-3rd month )

Methylprednisolone(intravenously in the 1st-3rd-5th month)

About this trial

This is an interventional treatment trial for Glomerulonephritis, IGA

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 14~65 years, regardless of gender
Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.
Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations.
eGFR ≥ 50 ml/min/1.73 m2
Willingness to sign an informed consent.

Exclusion Criteria:

Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.
Rapidly progressive nephritic syndrome (crescent formation≥50%).
Acute renal failure, including rapidly progressive IgAN.
Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
Date of renal biopsy exceeds more than 30 days.
Cirrhosis, chronic active liver disease.
History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
Any Active systemic infection or history of serious infection within one month.
Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).
Active tuberculosis
Malignant hypertension that is difficult to be controlled by oral drugs.
Known allergy, contraindication or intolerance to the steroids.
Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
Malignant tumors
Excessive drinking or drug abuse
Mental aberrations
Current or recent (within 30 days) exposure to any other investigational drugs.

Sites / Locations

Department of Nephrology,Dongguan People's HospitalRecruiting
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical UniversityRecruiting
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
Department of Nephrology,Huizhou Municipal Central HospitalRecruiting
Department of Nephrology,1st Affiliated Hospital,Shenzhen UniversityRecruiting
Department of Nephrology,1st People's Hospital of ZhaoqingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A 1-2-3Group

B 1-3-5Group

Arm Description

Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Outcomes

Primary Outcome Measures

Remission of proteinuria (complete or partial)

Secondary Outcome Measures

Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).

The longitudinal decline of kidney function(eGFR)

Full Information

NCT ID

NCT02160132

First Posted

June 3, 2014

Last Updated

March 2, 2015

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02160132

Brief Title

A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

Official Title

Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.

Detailed Description

It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

6. Conditions and Keywords

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

Glomerulonephritis, IGA, Peripapillary Crescent, Necrosis, Steroid Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A 1-2-3Group

Arm Type

Experimental

Arm Description

Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Arm Title

B 1-3-5Group

Arm Type

Active Comparator

Arm Description

Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone(intravenously in the 1st-2nd-3rd month )

Intervention Description

Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone(intravenously in the 1st-3rd-5th month)

Intervention Description

Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Primary Outcome Measure Information:

Title

Remission of proteinuria (complete or partial)

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Time Frame

up to 6 months

Title

The longitudinal decline of kidney function(eGFR)

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 14~65 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus. Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations. eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent. Exclusion Criteria: Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis. Rapidly progressive nephritic syndrome (crescent formation≥50%). Acute renal failure, including rapidly progressive IgAN. Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506). Date of renal biopsy exceeds more than 30 days. Cirrhosis, chronic active liver disease. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease). Any Active systemic infection or history of serious infection within one month. Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases). Active tuberculosis Malignant hypertension that is difficult to be controlled by oral drugs. Known allergy, contraindication or intolerance to the steroids. Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception. Malignant tumors Excessive drinking or drug abuse Mental aberrations Current or recent (within 30 days) exposure to any other investigational drugs.

Central Contact Person:

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

Zongpei Jiang, M.D. & Ph.D.

Phone

8620-38379727

jx.home@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zongpei Jiang, M.D. & Ph.D.

Organizational Affiliation

The Sixth Affiliated Hospital,Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nephrology,Dongguan People's Hospital

City

Dongguan

State/Province

Guangdong

ZIP/Postal Code

523059

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guohui Liu, MD

Phone

86769-28637333

liuguohui5@126.com

First Name & Middle Initial & Last Name & Degree

Guohui Liu, MD

Facility Name

Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianbo Liang, MD

Phone

8620-34152282

boliangjian@tom.com

First Name & Middle Initial & Last Name & Degree

Jianbo Liang, MD

Facility Name

Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zongpei Jiang, M.D. & Ph.D.

Phone

8620-38379727

jx.home@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Zongpei Jiang, M.D. & Ph.D.

Facility Name

Department of Nephrology,Huizhou Municipal Central Hospital

City

Huizhou

State/Province

Guangdong

ZIP/Postal Code

516001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weiqiang Zhong, MD

Phone

86752-2288288

13809669766@126.com

First Name & Middle Initial & Last Name & Degree

Weiqiang Zhong, MD

Facility Name

Department of Nephrology,1st Affiliated Hospital,Shenzhen University

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongcheng He, MD

Phone

86755-83366388

heyongcheng@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Yongcheng He, MD

Facility Name

Department of Nephrology,1st People's Hospital of Zhaoqing

City

Zhaoqing

State/Province

Guangdong

ZIP/Postal Code

526020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinquan Wu, MD

Phone

86758-2832139

zqwujq@163.com

First Name & Middle Initial & Last Name & Degree

Jinquan Wu, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35062886

Citation

Liang M, Xiong L, Li A, Zhou J, Huang Y, Huang M, Zhang X, Shi H, Su N, Wei Y, Jiang Z. The effectiveness and safety of corticosteroid therapy for IgA nephropathy with crescents: a prospective, randomized, controlled study. BMC Nephrol. 2022 Jan 21;23(1):40. doi: 10.1186/s12882-022-02661-6.

Results Reference

derived

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A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

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