Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse

NCT ID: NCT02216747

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Glomerular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

prednisone 60 mg/meter square Body Surface Area

Intervention Type: DRUG

treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms

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.

Group Type: ACTIVE_COMPARATOR

prednisone 45 mg

Intervention Type: DRUG

treatment with 45 mg prednisone to compare with other arms

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.

Group Type: ACTIVE_COMPARATOR

prednisone 30 mg

Intervention Type: DRUG

treatment with 30 mg prednisone to compare with other arms.

Interventions

prednisone 60 mg/meter square Body Surface Area

treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms

Intervention Type: DRUG

prednisone 45 mg

treatment with 45 mg prednisone to compare with other arms

Intervention Type: DRUG

prednisone 30 mg

treatment with 30 mg prednisone to compare with other arms.

Intervention Type: DRUG

Other Intervention Names

Danalon; Danalon; Danalon

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amit Dagan

DR. Amit Dagan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Dagan, Doctor

Role: PRINCIPAL_INVESTIGATOR

nephrology institute Shneider Children Hospital

Amit Dagan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Schneider childrens Hospital Nephrology Institute

Locations

Shneider children Hospital Nephrology Institute

Petah Tikva, , Israel

Countries

Israel

References

Hahn D, Samuel SM, Willis NS, Craig JC, Hodson EM. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD001533. doi: 10.1002/14651858.CD001533.pub7.

Reference Type: DERIVED

PMID: 39171624 (View on PubMed)

Other Identifiers

RMC14 6413 CTIL

Identifier Type: -

Identifier Source: org_study_id