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Status unknownNCT02532790Updated Feb 26, 2020

The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children

A Phase 2 interventional study of Prednisone and ACEI in Henoch-Schoenlein Purpura Nephritis, sponsored by Nanjing Children's Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Nanjing Children's Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 16 Years
Sex
All
01

Study summary

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

Read the detailed description

Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological markers for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

The patients who are proved to get HSPN by renal biopsy will be randomized to receive either prednisone p.o. or angiotensin-converting enzyme inhibitor(ACEI) p.o. We will follow up them for about 2.5 years and compare the efficacy and safety of both measures by monitoring several indexes.

02

Conditions studied

  • Henoch-Schoenlein Purpura Nephritis

Keywords

  • Mild proteinuria
03

In context

Lead sponsor

Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • The children with congenital diseases
  • Proteinuria≥25 mg/kg/d
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    group 1

    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

  • Experimental
    group 2

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

    Drug: ACEI

Interventions

  • DrugPrednisone

    1.5mg/kg/d

  • DrugACEI

    0.2-0.3mg/kg/d

    Also known as: Lotensin

06

What researchers measure

Primary outcomes

  1. Disappearance of proteinuria

    The proteinuria is \< 150mg/d

    Time frame: 30 months

Secondary outcomes

  1. Disappearance of hematuria

    The number of red blood cells is \< 3 in each high power field of vision

    Time frame: 30 months

  2. Renal function

    The glomerular filtration rate is normal

    Time frame: 30 months

07

Study locations

1 of 1 sites recruiting
  • Nanjing Children's Hospital
    Nanjing, Jiangsu 210000, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36853224 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Jul 2020 and a completion of Jul 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2015
First posted
Aug 26, 2015
Start
Aug 2015
Primary completionEst.
Jul 2020
CompletionEst.
Jul 2020
Last update
Feb 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02532790
Lead sponsor
Nanjing Children's Hospital
Responsible party
Aihua Zhang (Hospital vice president, Nanjing Children's Hospital) — Principal investigator
First posted
Aug 26, 2015
Start date
Aug 2015
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Feb 26, 2020

Study contacts

Aihua Zhang, M.D.
Contact
bszah@163.com
+8618951769017
Yimei Wu
Contact
wym891203@163.com
+8615951757930
Aihua Zhang, M.D.
study chair · Department of Nephrology, Nanjing children's hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Prednisone

Other studies from this sponsor

Nanjing Children's Hospital

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