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Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long term tapering of prednisolone | Drug | 60mg/m2/day (0-4 weeks); 60mg/m2 alternate days (5-6 weeks); 50mg/m2 alternate days (week 7-8); 40mg/m2 alternate days (week 9-10); 30mg/m2 alternate days (week 11-12); 20mg/m2 alternate days (week 13-14); 10mg/m2 alternate days (week 15-16) | ||
| standard prednisolone treatment | Drug | 60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse | 5 months | |
| Assessment of steroid induced morbidity | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| frequent relapsing and steroid dependant disease | 5 months | |
| Time to relapse | 5 months | |
| serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Trompeter | Contact | 0121 333 8741 | r.a.cook@bham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Richard Trompeter | Great Ormond Street Hospital | Principal Investigator |
| Peter Houtman | Children's Hospital, Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Child Health | Recruiting | London | WC1N 1EH | United Kingdom |
| 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. |
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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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| 5 months |
| use of other immunosuppressive agents | 5 months |
| Achenbach child behaviour checklist | 5 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |