EUCTR2015-002345-64-CZ进行中（未招募）不适用
A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion with Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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