EUCTR2015-002345-64-CZ
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IgA Nephropathy
- Sponsor
- Baxalta Innovations GmbH
- Enrollment
- 51
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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