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Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome (AJSNS)

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ClinicalTrials.gov Identifier: NCT02649413
Recruitment Status : Unknown
Verified December 2015 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 7, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the investigators will adjusted the first steroids does to the response day. Our primary end point is : a lower adjusted dose is as good as the fix dose in the first year after diagnosis.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome, Minimal Change Drug: Prednisone Phase 4

Detailed Description:
About 90% of the patients will response to steroid therapy. The initial steroid dose is between 2mg/kg or 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The bases of this treatment have been put in the early 70s. Since then most of the study were focused on the duration of the therapy with a results that 8-12 weeks course is as good as 6 month. Studies have showed no difference in response rate between 2mg/kg to 60m2' although the difference in the dose in young children can rich to 25%. Other retrospective analysis been show that patients who response in the first 7-9 days tend to have lass relapses than other patients. In our nephrology clinic the investigators there is ongoing clinical study on low doses of steroid therapy for relapse of nephritic syndrome with good results.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome
Study Start Date : March 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Early response to prednisone treatment
intervention -children that will have a remission in 8 days (response) will get an adjusted steroids dose treatment.children that have a remission between 9-28 days will get a regular steroid dose.
Drug: Prednisone
Children with Idiopathic Nephrotic syndrome will start 60 mg/m2 prednisone.children that response in 8 days will receive an adjusted dose while the rest of the group will receive the 4 weeks usually dose.
Other Name: corticosteroids




Primary Outcome Measures :
  1. The time until the first relapse [ Time Frame: 6 months ]
    All Children with Nephrotic Syndrome will start a dose of 60 mg/m2 prednisone.patients that will response in 8 days (the first day with a negative or trace in the urine deep stick test)will receive adjusted lower steroid dose.the outcome is the time until the first relapse( positive protein in deep stick urine test,or low serum albumin with positive urine deep stick).the control group is the historical data from a prospective malty center observation study.


Secondary Outcome Measures :
  1. Number of relapse during first year [ Time Frame: one year ]
    We will count the number of relapse episodes in the first year since diagnosis.



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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:

  • Children who recently have been diagnosed with nephrotic syndrome.

Exclusion Criteria:

  • Children with nephrotic syndrome that can not be treated with steroids.

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): NCT02649413


Contacts
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Contact: Amit Dagan, Dr. 9723-9253979 DaganA@clalit.org.il
Contact: Amit Dagan, Dr. 972-925379 DaganA@clalit.org.il

Locations
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Israel
Shneider children Hospital Nephrology Institute
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Amit Dagan, Dr. Shneider children Hospital Nephrology Institute

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02649413     History of Changes
Other Study ID Numbers: 695 RMC -AJSNS
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Syndrome
Disease
Pathologic Processes
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