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Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse (NS)

Primary Purpose

Glomerular Disease

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
prednisone 60 mg/meter square Body Surface Area
prednisone 45 mg
prednisone 30 mg
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerular Disease focused on measuring Idiopathic Nephrotic syndrome relapse

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Steroid resistance or treatment with Cyclosporin or Cellcept

Sites / Locations

  • Shneider children Hospital Nephrology Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

prednisone 60 mg/meter square Body Surface Aera

prednisone 45 mg/meter square BSA

prednisone 30 mg/meter squer BSA

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Nephrotic Syndrome Remission
Undetectable protein in urine for 3 days

Secondary Outcome Measures

Remission duration
The number of weeks since the patient stopped steroids therapy and was in a complete remission.

Full Information

First Posted
August 13, 2014
Last Updated
August 13, 2014
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02216747
Brief Title
Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse
Acronym
NS
Official Title
Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerular Disease
Keywords
Idiopathic Nephrotic syndrome relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prednisone 60 mg/meter square Body Surface Aera
Arm Type
Active Comparator
Arm Description
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.
Arm Title
prednisone 45 mg/meter square BSA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
prednisone 30 mg/meter squer BSA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
prednisone 60 mg/meter square Body Surface Area
Other Intervention Name(s)
Danalon
Intervention Description
treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
Intervention Type
Drug
Intervention Name(s)
prednisone 45 mg
Other Intervention Name(s)
Danalon
Intervention Description
treatment with 45 mg prednisone to compare with other arms
Intervention Type
Drug
Intervention Name(s)
prednisone 30 mg
Other Intervention Name(s)
Danalon
Intervention Description
treatment with 30 mg prednisone to compare with other arms.
Primary Outcome Measure Information:
Title
Nephrotic Syndrome Remission
Description
Undetectable protein in urine for 3 days
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Remission duration
Description
The number of weeks since the patient stopped steroids therapy and was in a complete remission.
Time Frame
Weeks
Other Pre-specified Outcome Measures:
Title
Edema
Description
A sign of treatment resistance or no response.
Time Frame
within 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment. Exclusion Criteria: Steroid resistance or treatment with Cyclosporin or Cellcept
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Dagan, Doctor
Organizational Affiliation
nephrology institute Shneider Children Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amit Dagan, Doctor
Organizational Affiliation
Schneider childrens Hospital Nephrology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shneider children Hospital Nephrology Institute
City
Petach-Tikva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Dagan, Doctor

12. IPD Sharing Statement

Learn more about this trial

Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

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