NCT00885547

Brief Summary

The purpose of this study is to:

  1. 1.To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
  2. 2.To evaluate the safety and tolerability of TW.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Status
terminated

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

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

April 20, 2009

Last Update Submit

March 31, 2015

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.

    12 months

Secondary Outcomes (1)

  • The percentage of total effect of the 3 groups and adverse event within the follow-up periods.

    12 months

Study Arms (1)

immunosuppressor

EXPERIMENTAL
Drug: tripterygium wilfordii (TW)

Interventions

tripterygium wilfordii (TW)DRUG

90 mg/d for 6 months

Also known as: tripterygium wilfordii
immunosuppressor

Eligibility Criteria

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

You may qualify if:

  • years old but no requirement for gender
  • All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
  • Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement

You may not qualify if:

  • Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
  • Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
  • Severe infection
  • Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
  • Women during pregnancy and lactation
  • Patients need to procreation lately
  • Patients treated with TW or ARB within 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zheng Tang, Doctor

    Nanjing University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

April 2, 2015

Record last verified: 2015-03