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Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

NCT02216747 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-08-15

No results posted yet for this study

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?

Conditions

  • Glomerular Disease

Interventions

DRUG

prednisone 60 mg/meter square Body Surface Area

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

DRUG

prednisone 45 mg

treatment with 45 mg prednisone to compare with other arms

DRUG

prednisone 30 mg

treatment with 30 mg prednisone to compare with other arms.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Amit Dagan, Doctor · nephrology institute Shneider Children Hospital

  • Amit Dagan, Doctor · Schneider childrens Hospital Nephrology Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216747 on ClinicalTrials.gov