IgA Nephropathy MedDRA version: 18.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Code: SM101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: SM101
Other descriptive name: human soluble recombinant Fc-gamma
Sponsors
Baxalta Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is 18 years of age or older at the time of Screening. 2. Subject may be of either gender and of any race or ethnicity. 3. Subject must have a biopsy-proven diagnosis of IgAN (obtained within 8 years prior to Screening). 4. Subject’s blood pressure is =130/80 mmHg at Screening. 5. Subject is on maximally tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin receptor blocker (ARB) for at least 3 month prior to Baseline visit. 6. Subject must present at Screening with current proteinuria levels between 1 g/24 h and 3.5 g/24 h. 7. Subject must present at Screening with eGFR [CKD-EPI] >40 mL/min/1.73m2. 8. If a female of childbearing potential, subject must have a negative pregnancy test at Screening, is not currently breastfeeding, and agrees to employ adequate birth control measures for the duration of the study. Male subjects with female partners of childbearing potential must agree to use adequate birth control measures for the duration of the study. 9. Subject is willing and able to comply with the requirements of this protocol and agrees to sign an informed consent form prior to any study-related activities. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Subject has a history or current evidence of renal disease other than IgAN 2. Subjects with evidence of rapidly progressive disease (defined as a decline in eGFR of =5 mL/min/1.73m2 in the preceding 6 months prior to Baseline) 3. Subject has IgAN with histologic evidence of advanced tubular atrophy and interstitial fibrosis (eg, Oxford T2) 4. History or current evidence of other autoimmune disease (eg, SLE, inflammatory bowel disease, rheumatoid arthritis) 5. History or current evidence of any chronic or uncontrolled medical condition (eg, diabetes, severe hepatic or cardiovascular disease, alcohol or drug addiction) which could, in the opinion of the Investigator, affect the subject’s safety and ability to adhere to this protocol, or otherwise confound the results of the study 6. History or current evidence of a severe acute (ie, within 4 weeks prior to Baseline) or chronic infection (eg, HIV, hepatitis B or C, tuberculosis, systemic fungal infection [active or latent]) 7. Use of systemic corticosteroids within 3 months prior to Baseline, or anticipated use during the treatment period (Week 1 through Week 4). Note: Corticosteroids administered by inhalation or intranasally, or limited topical use of low-potency topical corticosteroids (ie, Class 6 and 7) are allowed throughout the study. 8. Known hypersensitivity or allergic reaction to any E. coli-derived recombinant product, or to the IP or any of its excipients 9. Treatment with any immunomodulatory/immunosuppressive compound or monoclonal antibody for any indication within 6 months (unless otherwise stated) prior to Screening (eg, B cell-depleting agents [eg, rituximab, epratuzumab] for =48 weeks; B-cell modifying agents [eg, belimumab, atacicept] for =24 weeks; IV immunoglobulins for =12 weeks and all other immunosuppressive treatments [eg, methotrexate, cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine] for =12 weeks) 10. Clinically significant laboratory abnormalities prior to Baseline (eg, absolute neutrophil count <1000 cells/µL; platelet count <100,000/µL; hemoglobin =10 g/dL; aspartate aminotransferase [AST], and alanine aminotransferase [ALT] =3 times the upper limit of normal) 11. History of any malignancy within past 5 years prior to Screening (except for basal and squamous cell carcinomas of the skin, in situ cervical cancer, and stable prostate cancer that does not require treatment) 12. History of tonsillectomy within 2 months prior to Screening 13. Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to Screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study 14. Subject is a family member or employee of the Investigator 15. A female subject who is pregnant or nursing at the time of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a single treatment cycle of SM101 on the mean percent change in proteinuria from Baseline to Week 24 in subjects with IgAN;Primary end point(s): To assess the efficacy of a single treatment cycle of SM101 on the mean percent change in proteinuria from Baseline to Week 24 in subjects with IgAN 1. Pooled high-dose SM101 and low-dose SM101 versus placebo 2. High-dose SM101 versus placebo 3. Low- dose SM101 versus placebo ;Timepoint(s) of evaluation of this end point: Week 24;Secondary Objective: 1. To assess the safety and tolerability of SM101 in subjects with IgAN 2. To compare the relative efficacy and safety of 12 mg/kg and 24 mg/kg doses of SM101 in the treatment of IgAN 3. To assess the effect of SM101 on renal function, as determined by estimated glomerular filtration rate (eGFR) 4. To compare the effect of treatment with SM101 on the level of IgAN-specific biomarkers 5. To assess the pharmacokinetics (PK) of SM101 in subjects with IgAN | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pooled high-dose SM101 and low-dose SM101 versus placebo (testing via 2x2 table by pooling high- and low-dose SM101 into single column, using placebo as the second column). 2. High-dose SM101 versus placebo (testing via 2x2 table, using only SM101 high-dose and placebo) 3. Low- dose SM101 versus placebo (testing via 2x2 table, using only SM101 low-dose and placebo);Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Belgium, Canada, Czech Republic, Denmark, Germany, Hong Kong, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Development
Baxalta Innovation GmbH
Outcome results
None listed