ess prednisone for a nephrotic syndrome relapse

Phase 1

Conditions: ephrotic syndrome relapse in children
MedDRA version: 20.0Level: LLTClassification code 10029172Term: Nephrotic syndrome with unspecified pathological lesion in kidneySystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.1Level: PTClassification code 10029164Term: Nephrotic syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0Level: LLTClassification code 10029168Term: Nephrotic syndrome with lesion of minimal change glomerulonephritisSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0Level: LLTClassification code 10042826Term: Syndrome nephroticSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Not possible to specify

Registration Number: EUCTR2016-002430-76-NL

Lead Sponsor: Radboudumc, Amalia Children’s Hospital, Department of Pediatrics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 144

Inclusion Criteria

•Age over 1 and less than 18 years;
•Steroid sensitive nephrotic syndrome;
•At least 1 nephrotic syndrome relapse in the preceding 24 months that was treated with prednisolone;
•The last prednisolone use (at a dose over 10mg/m2 on alternate days) for the treatment of a previous episode was at least 4 weeks ago;
•Signed informed consent from the parent or legal assent and/or the patient, depending on the age of the patient.

Are the trial subjects under 18? yes
Number of subjects for this age range: 144
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Steroid resistant nephrotic syndrome;
•Receiving, or within 3 months after receiving, cyclophosphamide or rituximab;
•Daily prednisolone maintenance therapy at any dose;
•Alternate day prednisolone maintenance therapy at a dose over 4 mg/m2;
•Documented or suspected significant non-compliance;
•Pregnancy;
•Stimulant drug use;
•Comorbidity;
- Kidney transplant patients
- Any disease that requires the variation in oral prednisolone to be at the discretion of the treating physician(s);
•Concomitant use of drugs that induce CYP3A4: carbamazepine, phenobarbital, phenytoin and/or rifampicin;
•Concomitant use of drugs that inhibit CYP3A4: ketaconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics (erythromycin), diltiazem, verapamil.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective: <br>To study the effectiveness of a reduced steroid schedule for the treatment of a relapse in children with steroid sensitive nephrotic syndrome.<br>;Secondary Objective: Secondary Objective(s): <br>•To study the influence of maintenance immunosuppressive therapy on the effectiveness of a reduced steroid schedule for the treatment of a relapse in children with steroid sensitive nephrotic syndrome;<br>•To study the course of relapses in children with nephrotic syndrome under the standard treatment regimen;<br>•To study the influence of maintenance immunosuppressive therapy on the course of relapses in children with nephrotic syndrome under the standard treatment regimen.<br>;Primary end point(s): Time to first relapse after study randomization (censored at 12 and 24 months);Timepoint(s) of evaluation of this end point: 12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 12 and 24 months;Secondary end point(s): •Number of relapses after study randomization at 12 or 24 months<br>•Development of frequent relapsing nephrotic syndrome according to KDIGO criteria (four or more relapses in any 12-month period)<br>•Development of steroid dependent nephrotic syndrome according to KDIGO criteria (two consecutive relapses during corticosteroid therapy, or within 14 days of ceasing therapy)<br>•Cumulative dosage of prednisolone during study period (at 12 and 24 months)<br>