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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02216747
Other study ID # RMC14 6413 CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 13, 2014
Last updated August 13, 2014
Start date September 2014
Est. completion date December 2015

Study information

Verified date August 2014
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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?


Description:

Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The first line of therapy is prednisone and about 90% of the patients will

response to this treatment. The course of the disease is characterized of

recurrent relapses and repeated prednisone therapy. While prednisone doses and

therapy duration in the disease diagnosis has been based on multiple prospective

studies, the dose and therapy duration in the relapses was never challenged in a

prospective control study.

To address this question we designed prospective 3 arm study to evaluate the

effective of exception steroid regiment to treat relapses versus lower doses.

The study population is children in the age 2-18 year old with steroid sensitive nephrotic syndrome.

After relapse will be diagnosed based on physical exam and urine tests, the

patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2.

A measurement of time to obtain remission, duration of remission est. will be collected.

We plan to recruit 100 children in this study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Steroid resistance or treatment with Cyclosporin or Cellcept

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
prednisone 60 mg/meter square Body Surface Area
treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
prednisone 45 mg
treatment with 45 mg prednisone to compare with other arms
prednisone 30 mg
treatment with 30 mg prednisone to compare with other arms.

Locations

Country Name City State
Israel Shneider children Hospital Nephrology Institute Petach-Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Edema A sign of treatment resistance or no response. within 14 days Yes
Primary Nephrotic Syndrome Remission Undetectable protein in urine for 3 days 3 days No
Secondary Remission duration The number of weeks since the patient stopped steroids therapy and was in a complete remission. Weeks No
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