Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

Glomerular Disease Clinical Trial

— NS  

Official title:

Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02216747
• Other study ID #: RMC14 6413 CTIL
• 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

• Glomerular Disease
• Nephrosis
• Nephrotic Syndrome

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