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

Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose

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?

Study Overview

• Status: Unknown
• Conditions: Glomerular Disease
• Intervention / Treatment: Drug: prednisone 60 mg/meter square Body Surface Area; Drug: prednisone 45 mg; Drug: prednisone 30 mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel
    • Shneider children Hospital Nephrology Institute
    • Principal Investigator: Amit Dagan, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prednisone 60 mg/meter square Body Surface Aera; 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; treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms; Other Names: Danalon
Active Comparator: prednisone 45 mg/meter square BSA; 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; treatment with 45 mg prednisone to compare with other arms; Other Names: Danalon
Active Comparator: prednisone 30 mg/meter squer BSA; 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; treatment with 30 mg prednisone to compare with other arms.; Other Names: Danalon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nephrotic Syndrome Remission	Undetectable protein in urine for 3 days	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission duration	The number of weeks since the patient stopped steroids therapy and was in a complete remission.	Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edema	A sign of treatment resistance or no response.	within 14 days

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Amit Dagan, Doctor, nephrology institute Shneider Children Hospital; Principal Investigator: Amit Dagan, Doctor, Schneider childrens Hospital Nephrology Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Idiopathic Nephrotic syndrome relapse
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Recurrence; Nephrotic Syndrome; Nephrosis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: RMC14 6413 CTIL