NL-OMON50633已完成3 期
A double-blind, randomized-withdrawal, placebo-controlled study to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care for the treatment of refractory antibody mediated rejection in adult renal transplant recipients - N/A
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provide written informed consent and willing and able to adhere to all
- •protocol requirements.
- •2. At least 18 years of age at the time of providing written informed consent.
- •3. Evidence of at least one DSA (to HLA class I and/or class II)
- •4. Recipient of a kidney transplant from an ABO compatible or ABO incompatible
- •donor, living or deceased.
- •5. At least one of the following if clinical data are available:
- •a. Achieved a steady-state, post-transplant eGFR * 40 mL/min/1.73 m2 (as
- •determined by local practice) within 60 days post-transplant, , OR
- •b. A 50% increase in urine output with a 50% decrease in serum creatinine over
- •the first 7 days post-transplant in subjects with slow or delayed graft
- •6. Acute AMR defined per Banff 2015 criteria [Loupy et al, 2017] on pre
- •enrollment kidney biopsy (performed within 90 days of enrollment, as the
- •a. Histologic evidence of acute tissue inflammation with presence of
- •neutrophils and/or monocytes (g > 0, v > 0, and/or ptc > 0), AND
- •b. C4d positive or, if C4d negative, then g + ptc * 2.
- •NOTE: Subjects who have mixed cellular rejection with AMR are eligible for
- •participation.
- •7. Acute AMR that is unresponsive (ie, no improvement in renal function as
- •determined by the treating physician) after standard of care treatment:
- •a. If standard of care treatment is * 100 mg/kg IVIg and plasmapheresis - with
- •or without rituximab -: * 7 days since the current AMR diagnosisat the Day 1
- •b. If standard of care treatment is * 1 gram/kg IVIg without plasmapheresis -
- •with or without rituximab: * 45 days since the current AMR diagnosis.
- •8. Subject must be willing and able to comply with the requirements of the
- •study protocol.
- •9. Investigator believes that the subject understands the nature, scope and
- •possible consequences of the study.
排除标准
- •1. Recipient of an en bloc kidney transplant
- •2. Ongoing dialysis > 2 weeks at Screening.
- •3. Hepatobiliary disease as indicated by 1 of the following:
- •a. Viral hepatitis ie, positive for HCV or HBV confirmed by nucleic acid
- •testing (if positive, subjects
- •must be receiving or have received antiviral therapy and have no history
- •of cirrhosis), OR
- •b. Alanine aminotransferase > 3 times upper limit of normal, OR
- •c. Total bilirubin > 1.5 times upper limit of normal.
- •4. History of human immunodeficiency virus with acquired immunodeficiency
- •at Screening.
- •5. Active bacterial or fungal infection that is clinically significant in the
- •opinion of the investigator.
- •6. Not otherwise explained thrombotic microangiopathy on pre-enrollment kidney
- •7. Known congenital bleeding or coagulopathy disorder.
- •8. Evidence of non-catheter or non dialysis access-related deep vein
- •thrombosis, stroke, myocardial infarction, or arterial embolus within the 3
- •months before the Day 1 Visit; catheter-related thrombosis or history of
- •clotting a dialysis access is NOT exclusionary, unless a hereditary
- •coagulopathy has been diagnosed..
- •9. Treatment with a complement inhibitor (eg, Soliris [eculizumab], Berinert
- •[C1-INH], Cinryze [C1-INH]), or experimental therapies for the treatment of AMR
- •other than IVIg or rituximab (eg, bortezomib) within 14 days before
- •administration of C1-INH at the Day 1 Visit.
- •10. Current cancer or a history of cancer within 2 years before providing
- •informed consent, with the exception of successfully treated non-metastatic
- •basal or squamous cell carcinoma of the skin, in situ breast or other in situ
- •lesions considered cured by therapy
- •11. Any medical condition that, in the opinion of the investigator, might
- •interfere with the subject participation in the study, poses an added risk to
- •the subject, or confounds the assessment of the subject.
- •12. Female subjects who are pregnant (as evidenced by a positive serum
- •pregnancy test for choriogonadotropin beta at Screening) or breast feeding.
- •13. Female subject of childbearing potential or male subject not using or not
- •willing to use a medically reliable method of contraception from the first dose
- •of investigational product in any treatment period until 1 month after the last
- •dose of investigational product in the same treatment period.
- •NOTE: Childbearing potential and the acceptable methods of contraception are
- •defined in Section 7.4.
- •14. Participation in another interventional clinical study for AMR at
- •Screening; subject may have been withdrawn from an AMR study at any time before
- •15. Known or suspected hypersensitivity to the investigational product (ie,
- •C1-INH or placebo), to any excipients of the investigational product, or to any
- •other C1-esterase inhibitor preparation (eg, Berinert) or albumin preparation.
- •16. Involved in the planning and/or conduct of the study (applies to CSL staff,
- •staff at the study site, and third-party vendors).
研究者
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