NCT01879514

Brief Summary

IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.

Trial Health

55
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

3.9 years

First QC Date

March 25, 2013

Last Update Submit

June 13, 2013

Conditions

IgA Nephropathy

Keywords

IgA nephropathyTherapy of Chinese medicine

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate

    Evaluation of renal function indicators

    12 months

Secondary Outcomes (1)

  • 24 hours urine protein

    12 months

Study Arms (2)

Combination Group

EXPERIMENTAL

Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks

Drug: Chinese Herb Prescription Granule plus prednisone

Placebo

PLACEBO COMPARATOR

Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks

Drug: Placebo

Interventions

Chinese Herb Prescription Granule plus prednisoneDRUG

Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule

Combination Group
PlaceboDRUG

Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.
  • Pathology:upon Lee's grade Ⅲ
  • Age :18-60 years old.
  • Gender and nationality are not limited
  • Chronic Kidney Disease(CKD) Stage 3:（59 ml/min\>GFR\>30ml/min/1.73m2）
  • hour urine protein:≥1.0g.Informed consent

You may not qualify if:

  • Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks
  • Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks
  • Patients suffering from acute or rapidly progressive glomerulonephritis
  • Patients continue with active hepatitis B and abnormal liver function tests transaminase
  • Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents
  • Abnormal glucose metabolism, fasting blood glucose more than 6.2mmol/L
  • Pregnancy or breast-feeding women
  • Receiving other clinical trials
  • Associated with other serious diseases and organ dysfunction
  • Combined life-threatening complications such as severe infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology,Longhua Hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Prednisone

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • YueYi Deng, PHD,MD

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YUEYI DENG, Dr.

CONTACT

64385700lhkidney@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 25, 2013

First Posted

June 17, 2013

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

CN(1)