ess prednisone for a nephrotic syndrome relapse

Phase 1

Active, not recruiting

Conditions: ephrotic syndrome relapse in children
MedDRA version: 21.1Level: LLTClassification code 10029172Term: Nephrotic syndrome with unspecified pathological lesion in kidneySystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1Level: PTClassification code 10029164Term: Nephrotic syndromeSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Not possible to specify
MedDRA version: 21.1Level: 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

Registration Number: EUCTR2016-002430-76-BE

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 144

Inclusion Criteria

• Age over 1 and less than 18 years;
• Steroid sensitive nephrotic syndrome;
• The last prednisolone use (at a dose over 10 mg/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;
• 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;
oKidney transplant recipient;
oAny disease that requires the variation in oral prednisolone to be at the discretion of the treating physician(s);
• Concomitant use of drugs that induce CYP 3A4: carbamazepine, phenobarbital, phenytoin and/or rifampicin;
• Concomitant use of drugs that inhibit CYP 3A4: ketaconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics (erythromycin), diltiazem, verapamil.