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This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 months group | Placebo Comparator | Subjects will receive 12-weeks of placebo following randomization |
|
| 6 months group | Experimental | 12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | 12 weeks prednisolone treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment | Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment. | 12 month period after 3 month standard treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of relapses during 12 months follow up after 3 month standard treatment | Number of nephrotic syndrome relapses per patient year during the 12-month period after 3 month standard treatment | 12 month period after 3 month standard treatment |
| Time to first relapse (days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Xu, PhD.MD. | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital of Fudan university | Shanghai | Shanghai Municipality | 200000 | China | ||
| Shanghai Children's Hospital |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Drug | 12 weeks simulated tablets |
|
Number of days from randomization to occurrence of first relapse |
| 12 month period after 3 month standard treatment |
| Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment | Total amount of prednisolone [or corticosteroid equivalent] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months follow up after 3 month standard treatment | 12 month period after 3 month standard treatment |
| The use of steroid-sparing medications | The proportion of patients in each study arm treated with steroid-sparing strategies or medications.it is a binary varibale (1/0). The variable wolud be sette into "1", if the patients use the steroid-sparing medications such as cyclophosphamide, levamisole, mycophenolate mofetil，rituximab and so on. | 12 month period after 3 month standard treatment |
| Adverse events during 12-month period after 3 month standard treatment | Number of adverse events experienced, related or unrelated to corticosteroid use | 12 month period after 3 month standard treatment |
| Change in height during 12-month period after 3 month standard treatment | The standard deviation scores (SDS) for height will be measured at 12th month and randomization. Change in height is SDS at 12 month minus that of randomization. | 12 month period after 3 month standard treatment |
| Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment | Proportion of patients with steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment.Steroid-dependent nephrotic syndrome was defined as steroid-sensitive nephrotic syndrome with 2 or more consecutive relapses during tapering or within 14 days of stopping steroids. | 12 month period after 3 month standard treatment |
| Shanghai |
| China |
| Shanghai Children's Medical Center | Shanghai | China |
| Xinhua Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |