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

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ClinicalTrials.gov Identifier: NCT02216747
Recruitment Status : Unknown
Verified August 2014 by Amit Dagan, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Amit Dagan, Rabin Medical Center

Study Description
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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?


Condition or disease Intervention/treatment Phase
Glomerular Disease Drug: prednisone 60 mg/meter square Body Surface Area Drug: prednisone 45 mg Drug: prednisone 30 mg Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
Study Start Date : September 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arms and Interventions
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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 Name: 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 Name: 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 Name: Danalon


Outcome Measures
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Primary Outcome Measures :
  1. Nephrotic Syndrome Remission [ Time Frame: 3 days ]
    Undetectable protein in urine for 3 days


Secondary Outcome Measures :
  1. Remission duration [ Time Frame: Weeks ]
    The number of weeks since the patient stopped steroids therapy and was in a complete remission.


Other Outcome Measures:
  1. Edema [ Time Frame: within 14 days ]
    A sign of treatment resistance or no response.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216747


Locations
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Israel
Shneider children Hospital Nephrology Institute
Petach-Tikva, Israel
Principal Investigator: Amit Dagan, Doctor         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Amit Dagan, Doctor nephrology institute Shneider Children Hospital
Principal Investigator: Amit Dagan, Doctor Schneider childrens Hospital Nephrology Institute
More Information
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Responsible Party: Amit Dagan, DR. Amit Dagan, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02216747    
Other Study ID Numbers: RMC14 6413 CTIL
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Amit Dagan, Rabin Medical Center:
Idiopathic Nephrotic syndrome relapse
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Recurrence
Pathologic Processes
Disease Attributes
Kidney Diseases
Urologic Diseases
Prednisone
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents