NCT00301613

Brief Summary

This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
Last Updated

May 27, 2010

Status Verified

July 1, 2008

Enrollment Period

2.3 years

First QC Date

March 10, 2006

Last Update Submit

May 25, 2010

Conditions

Henoch-Schoenlein PurpuraNephritis

Keywords

Henoch-Schonlein purpura nephritis Mycophenolate mofetilCyclophosphamidetreatment

Outcome Measures

Primary Outcomes (1)

  • To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

    12 months

Study Arms (1)

Mycophenolate mofetil

ACTIVE COMPARATOR
Drug: Mycophenolate mofetil

Interventions

Mycophenolate mofetilDRUG

MMF,1.0g/d

Also known as: Mycophenolate mofetil,cellcept
Mycophenolate mofetil

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years
  • Biopsy proved HSP
  • Proteinuria ≥ 3.0 g/24hr
  • Scr \< 5.0 mg/dl

You may not qualify if:

  • Cytotoxic drug treatment such as CTX, CsA, MMF for morn than 1 month-3 months prior to enrolled
  • Pregnancy
  • Active/serious infections
  • Previous diagnosed diabetes mellitus type 1 or 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

  • Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.

    PMID: 36853224DERIVED

MeSH Terms

Conditions

IgA VasculitisNephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune Complex DiseasesHypersensitivityImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Zhi-Hong Liu, M.D.

    Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 13, 2006

Study Start

January 1, 2003

Primary Completion

May 1, 2005

Study Completion

January 1, 2006

Last Updated

May 27, 2010

Record last verified: 2008-07

Locations

CN(1)