NCT02216747

Brief Summary

Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well. Response to this treatment is the most important prognostic factor and this patients has a benign disease course. 60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration. guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion. Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?

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_4

Timeline
Completed

Started Sep 2014

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

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

1.1 years

First QC Date

August 13, 2014

Last Update Submit

August 13, 2014

Conditions

Glomerular Disease

Keywords

Idiopathic Nephrotic syndrome relapse

Outcome Measures

Primary Outcomes (1)

  • Nephrotic Syndrome Remission

    Undetectable protein in urine for 3 days

    3 days

Secondary Outcomes (1)

  • Remission duration

    Weeks

Other Outcomes (1)

  • Edema

    within 14 days

Study Arms (3)

prednisone 60 mg/meter square Body Surface Aera

ACTIVE COMPARATOR

A - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end.

Drug: prednisone 60 mg/meter square Body Surface Area

prednisone 45 mg/meter square BSA

ACTIVE COMPARATOR

B- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended.

Drug: prednisone 45 mg

prednisone 30 mg/meter squer BSA

ACTIVE COMPARATOR

C- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended.

Drug: prednisone 30 mg

Interventions

prednisone 60 mg/meter square Body Surface AreaDRUG

treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms

Also known as: Danalon
prednisone 60 mg/meter square Body Surface Aera
prednisone 45 mgDRUG

treatment with 45 mg prednisone to compare with other arms

Also known as: Danalon
prednisone 45 mg/meter square BSA
prednisone 30 mgDRUG

treatment with 30 mg prednisone to compare with other arms.

Also known as: Danalon
prednisone 30 mg/meter squer BSA

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.

You may not qualify if:

  • Steroid resistance or treatment with Cyclosporin or Cellcept

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shneider children Hospital Nephrology Institute

Petah Tikva, Israel

Location

Related Publications (1)

  • Hahn D, Samuel SM, Willis NS, Craig JC, Hodson EM. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD001533. doi: 10.1002/14651858.CD001533.pub7.

    PMID: 39171624DERIVED

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Amit Dagan, Doctor

    nephrology institute Shneider Children Hospital

    PRINCIPAL INVESTIGATOR

  • Amit Dagan, Doctor

    Schneider childrens Hospital Nephrology Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR. Amit Dagan

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

IL(1)