Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prednisone 60 mg/meter square Body Surface Aera | Active Comparator | 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. |
|
| prednisone 45 mg/meter square BSA | Active Comparator | 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. |
|
| prednisone 30 mg/meter squer BSA | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone 60 mg/meter square Body Surface Area | Drug | treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nephrotic Syndrome Remission | Undetectable protein in urine for 3 days | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Remission duration | The number of weeks since the patient stopped steroids therapy and was in a complete remission. | Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Edema | A sign of treatment resistance or no response. | within 14 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amit Dagan, Doctor | nephrology institute Shneider Children Hospital | Principal Investigator |
| Amit Dagan, Doctor | Schneider childrens Hospital Nephrology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shneider children Hospital Nephrology Institute | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39171624 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| prednisone 45 mg | Drug | treatment with 45 mg prednisone to compare with other arms |
|
|
| prednisone 30 mg | Drug | treatment with 30 mg prednisone to compare with other arms. |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |