NCT02532790

Brief Summary

This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN with mild proteinuria in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

August 20, 2015

Last Update Submit

February 25, 2020

Conditions

Henoch-Schoenlein Purpura Nephritis

Keywords

Mild proteinuria

Outcome Measures

Primary Outcomes (1)

  • Disappearance of proteinuria

    The proteinuria is \< 150mg/d

    30 months

Secondary Outcomes (2)

  • Disappearance of hematuria

    30 months

  • Renal function

    30 months

Study Arms (2)

group 1

EXPERIMENTAL

Prednisone Drug : prednisone 1.5mg/kg/d for 4-6 weeks, then 1.5mg/kg/d qod for 4 weeks, reduce 5mg every 2-4 weeks If the proteinuria decreases by less than 50% after treating for two months, this candidate reaches the ending point.

Drug: Prednisone

group 2

EXPERIMENTAL

Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)

Drug: ACEI

Interventions

PrednisoneDRUG

1.5mg/kg/d

group 1
ACEIDRUG

0.2-0.3mg/kg/d

Also known as: Lotensin
group 2

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Renal biopsy proved HSPN (ISKDC class II)
  • Proteinuria \< 25 mg/kg/d

You may not qualify if:

  • The children with congenital diseases
  • Proteinuria≥25 mg/kg/d

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Children's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

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

Interventions

Prednisonebenazepril

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Aihua Zhang, M.D.

    Department of Nephrology, Nanjing children's hospital

    STUDY CHAIR

Central Study Contacts

Aihua Zhang, M.D.

CONTACT

+8618951769017bszah@163.com

Yimei Wu

CONTACT

+8615951757930wym891203@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital vice president

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 26, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

CN(1)