Immunoglobulin A (IgA) nephropathy MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: BENLYSTA® (belimumab)
Product Name: BENLYSTA® (belimumab)
Product Code: GSK1550188
Pharmaceutical Form: Solution for injection in pre-filled
Benlysta
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of t
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects with IgAN, aged between 18-75 years • Biopsy proven IgAN, with an IgAN Oxford Classification Score of M1 and/or E1 and T0/1 • Clinically active disease, defined by proteinuria = 0.5 g/24h (PCR = 50 mg/mmol) on two separate occasions despite at least 3 months of maximized supportive therapy • Female subjects not of child bearing potential, or of child bearing potential agreeing to use one of the contraceptive methods listed in the protocol Other protocol defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Secondary cause of IgAN, or renal impairment due to a condition that is not IgAN • Severely reduced or deteriorating kidney function, defined by an eGFR 15% decrease in eGFR in 3 months before screening • Nephrotic syndrome • Uncontrolled hypertension (>150/90 mmHg) • Concomitant or recent immunosuppression • Participation in another clinical trial of an investigational medicinal product (a minimum period of 1 year will be allowed between study completion of a biological investigational agent and commencement of this study, or 2 months for a non-biologic investigational agent) • Use of traditional herbal medicines • Prior use of biologic and/or cytotoxic therapies, and/or live vaccines within specified time periods • Major organ transplant • Malignant neoplasm within last 5 years • Acute, chronic or recurrent infection • Liver disease or abnormal liver function tests • Significant unstable or uncontrolled co-morbid conditions • Positive serology (HIV, Hepatitis B or C) • History of primary immunodeficiency • Significant IgG deficiency • IgA deficiency • Laboratory test abnormalities • Drug sensitivity/anaphylaxis • Drug or alcohol abuse or dependence • Blood donation during the study period • Serious suicide risk or suicidal ideation Other protocol defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether treatment with belimumab for 12 months can modulate proteinuria in patients with IgA nephropathy.; Secondary Objective: • To evaluate whether treatment with belimumab for 12 months can modulate autoantigen and antibody production in IgA nephropathy. • To evaluate the safety and tolerability of 12 months treatment with belimumab in IgA nephropathy. • To evaluate the effect of belimumab compared to placebo on renal function in IgA nephropathy. • To evaluate the effect of 12 months treatment with belimumab on pharmacodynamic (PD) markers and other markers of autoimmunity and their relationship with clinical measures in IgA nephropathy. • To evaluate the effect of 12 months treatment with belimumab on quality of life in IgA nephropathy. • To evaluate the sustainability of any change in proteinuria, PD markers and quality of life in the 12 months following treatment with belimumab. ;Primary end point(s): • Percent change from baseline in proteinuria at Week 52;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 52 and 104 depending on endpoint; Secondary end point(s): • Change from baseline in proteinuria levels • Change from baseline in autoantigen and antibody production • Safety and tolerability, as assessed by evaluation of adverse events (AE), clinical laboratory assessments (clinical chemistry, haematology, urinalysis), and vital signs • Change from baseline in renal function (serum creatinine, eGFR) • Change from baseline in pharmacodynamic/biomarker endpoints, which may include B and T cell populations, cytokines/chemokines, autoantibody profile, as data permit • Change from baseline in SF-36 v2 Quality of Life (QoL) questionnaire score | — |
Countries
United Kingdom
Contacts
Public ContactDr. Chee Kay Cheung
University of Leicester
Outcome results
None listed