E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Childhood nephrotic syndrome |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether an extended course of prednisolone reduces the time to first relapse in children presenting with steroid sensitive nephrotic syndrome. |
|
E.2.2 | Secondary objectives of the trial |
To determine whether an extended course of prednisolone i] reduces relapse rate ii] reduces the proportion of children who develop frequently relapsing or steroid dependent disease iii] reduces the requirement for second and third line immunosuppressive agents including levamisole, cyclophosphamide, ciclosporin, tacrolimus and mycophenolate mofetil iv] is associated with an increased incidence of steroid-related adverse events including behavioural problems v] is more cost effective than standard course therapy |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children presenting with the first episode of steroid sensitive NS who meet all of the following criteria: • Urine albumin: creatinine ratio > 200mg/mmol or protein:creatinine ratio >200mg/mmol, determined quantitatively on an early morning urine sample. • Serum/plasma albumin level < 25g/L • Age over 1 year and less than 15 years at the time of diagnosis • No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice). • No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome • Informed consent |
|
E.4 | Principal exclusion criteria |
• Children with histological changes other than minimal lesion glomerulonephritis where renal biopsy has been undertaken • Children with a prior history of poor compliance with medical therapy. • Known allergy to prednisolone |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to first relapse. Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
16wk tapering prednisolone regimen compared with standard 8wk prednisolone regimen |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 77 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of trial will be 6 months after the last data capture. The last data capture will be 2 years following recruitment of the last patient. Recruitment will take place over a period of 2 years. This will allow sufficient time for the completion of protocol procedures, data collection and data input. The Trials Office will notify the MHRA and main REC that the trial has ended and will provide them with a summary of the clinical trial report within 12 months of the end of trial . |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |