Belimumab for the treatment of frequently relapsing nephrotic syndrome

Phase 1

• Conditions: frequently relapsing nephrotic syndrome; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2017-003839-11-IT
• Lead Sponsor: IRCCS Ospedale PedT..trico Bambino Gesù

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-01
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

a.Age =3 years and <18 years, at enrolment
b.Frequently relapsing forms of INS, defined as two or more relapses per 6 months (or 4 or more per 12 month period) following the initial therapy or a relapse therapy (Vivarelli 2016). Relapse is defined as 3+ positive dipsticks on 3 consecutive days or by positive dipsticks (1+ to 3+) for 7 consecutive days.
c.Normal renal function (creatinine clearance > 90 ml/min/1.73 m2, as calculated by the Schwartz formula)
d.Remission of INS at enrolment
e.Patients that are on maintenance PDN treatment at a dose higher than 10 mg/m2 on alternate days
f.Expected compliance from the patient and his parents to the study protocol
g.Signed Informed Consent Form (ICF)/Assent by the subject’s parent(s) or legal representative(s). Children will be informed about the study and will be asked to give their assent as appropriate, depending on age.
h.If applicable, female participants must have pregnancy test by beta-HCG dosing and be negative.

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
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

a.Patients suffering from co-morbidities that are not related to INS, including malignancies
b.Patients with the following infections: HIV, hepatitis B and
c.Patients with any other chronic infectious condition
d.Patients with steroid-resistant INS
e.Patients that have achieved remission in more than 21 days during their last relapse (i.e. patients at risk of secondary steroid resistance)
f.Patients that have relapsed in the past year while receiving more than 30 mg/m2 of PDN on alternate days (i.e. severe steroid dependence that may require immediate initiation of additional immunosuppressive medication)
g.Patients that are have been treated with other immunosuppressive drugs in the last 12 months, particularly with drugs that inhibit B cell function (cyclophosphamide, micophenolate mofetil)
h.Patients that have been treated with rituximab
i.Patients that have received live vaccines in the 30 days previous to study initiation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified