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Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

Primary Purpose

IGA Nephropathy

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Prednisolone

Reh-acteoside

About this trial

This is an interventional treatment trial for IGA Nephropathy focused on measuring IGA Nephropathy, proteinurien, Reh-acteoside, Prednisolone

Eligibility Criteria

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

Inclusion Criteria:

Age 14~70 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy. Average urinary protein excretion of 1.0~3.5g/24h on two successive examinations.

eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent (patients under 18 years old need legal guardian to sign).

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. Renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) Current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).

Recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis B or hepatitis C infection), a rise more than 2.5 folds of current ALT, AST or TBil level.

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, 6th Affiliated Hospital, Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Prednisolone

Reh-acteoside

Reh-acteoside+Prednisolone

Arm Description

Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Oral take reh-acteoside (0.4g bid) for 8 weeks

Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks

Outcomes

Primary Outcome Measures

Remission of proteinuria (complete or partial)

Complete remission: UPCR (urinary protein creatinine ratio) <300mg/g, plasma albumin in normal range, and stable serum creatinine level (fluctuation range <15%)； Partial remission: UPCR decreases more than 50% from baseline, plasma albumin >30g/L, and stable serum creatinine level (fluctuation range <15%).

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

Deacrase of hematuria

urine RBC decreases more than 50% from baseline

Full Information

NCT ID

NCT02662283

First Posted

January 20, 2016

Last Updated

February 1, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02662283

Brief Title

Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

Official Title

Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy -- A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

November 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 reh-acteoside therapy for patients of IgA nephropathy.

Detailed Description

Reh-acteoside (general acteoside of rehmanniae leaves) contains more than 10 kinds of bio-active mucopolysaeccharide, among which acteoside is the most effective ingredient, constituting 30 percent. It has been reported that acteoside can reduce mesangium lesion of IgA nephrology-model ddy-mice, mainly by reducing the expressing of TGF-β1, reducing proliferation of mesangial cell and glomerular sclerosis. Research also suggested that conjunctive use of reh-acteoside and benazepril showed better effect on reducing proteinurine than single use of benazepril, with no obvious side effect at the same time. Thus, we start this clinical trial to evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy. We set 3 groups: methylprednisolone group, reh-acteoside group and methylprednisolone with reh-acteoside group. After followed-up for 8 weeks, remission of proteinuria and change of renal function will be evaluated.

6. Conditions and Keywords

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

IGA Nephropathy

Keywords

IGA Nephropathy, proteinurien, Reh-acteoside, Prednisolone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prednisolone

Arm Type

Active Comparator

Arm Description

Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Arm Title

Reh-acteoside

Arm Type

Experimental

Arm Description

Oral take reh-acteoside (0.4g bid) for 8 weeks

Arm Title

Reh-acteoside+Prednisolone

Arm Type

Experimental

Arm Description

Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Intervention Description

Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Reh-acteoside

Intervention Description

Oral take and reh-acteoside (0.4g bid) for 8 weeks

Primary Outcome Measure Information:

Title

Remission of proteinuria (complete or partial)

Description

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

Deterioration of renal function

Description

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

Time Frame

up to 8 weeks

Title

Deacrase of hematuria

Description

urine RBC decreases more than 50% from baseline

Time Frame

up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 14~70 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy. Average urinary protein excretion of 1.0~3.5g/24h on two successive examinations. eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent (patients under 18 years old need legal guardian to sign). 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. Renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) Current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506). Recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis B or hepatitis C infection), a rise more than 2.5 folds of current ALT, AST or TBil level. 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, 6th Affiliated Hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

12. IPD Sharing Statement

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Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

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