NL-OMON49228尚未招募不适用
Multicentric, randomized trial to evaluate the efficacy of baseline Immune-risk stratification based on selective Biomarkers (HLA Eplet mismatching and donor-specific IFN-γ ELISPOT) to optimize Immunosuppressive therapy in Living-kidney transplant patients - BIOIMM
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female patients >= 18 years old.
- •Recipients of a primary kidney transplant from a living non-HLA identical
- •donor (at least 1 HLA missmatch).
- •Compatible ABO transplant.
- •Patients with a calculated PRA (cPRA) <= 75% by solid-phase assays and
- •absence of donor-specific anti-HLA antibodies (DSA) against class I and class
- •II in an actual or historical screened sera.
- •Written informed consent must be obtained before any assessment is performed.
- •Women of child-bearing potential must use highly reliable contraceptive
- •methods (Pearl-Index <1) in order to avoid pregnancy during the entire duration
- •of the study and up to 6 weeks after the end of their treatment with
- •Mycophenolate Mofetil (MMF). Women of child-bearing potential include any woman
- •who has experienced menarche and who has not undergone successful surgical
- •sterilization (hysterectomy, bilateral tubal ligation or bilateral
- •oophorectomy) or who is not post-menopausal (defined as amenorrhea >= 12
- •consecutive months, or women who are receiving hormone replacement therapy with
- •a documented level of follicle stimulating hormone (FSH)> 35 mlU / ml). Women
- •of child-bearing potential must have a pregnancy test with a negative result in
- •the 72 hours prior to the start of the trial.
- •Sexually active males (also vasectomized men) receiving MMF must use a condom
- •during MMF treatment and the following 90 days. Fertile partners must use an
- •effective method of contraception.
- •Patients must agree not to donate blood during MMF treatment and for 6 weeks
- •thereafter. Males should not donate sperm during MMF treatment and up to 90
- •days after completion.
排除标准
- •Patients with a calculated PRA (cPRA) > 75% by solid-phase assays and/or
- •presence of donor-specific anti-HLA antibodies (DSA) against class I and class
- •II in an actual or historical screened sera.
- •Positive pre-transplant Cross Match test (either CDC or FCXM).
- •Recipients of a deceased donors.
- •HLA identical subjects
- •Multi-organ transplant recipients or prior kidney transplant.
- •Patients with one of the following diseases:
- •o Primary focal and segmental glomerulosclerosis
- •o Atypical Uremic Hemolytic Syndrome (aHUS) / Thrombotic Thrombocytopenic
- •Patients with active infection with Hepatitis B virus (HBV) and / or active
- •infection with Hepatitis C virus (positive PCR result) at the time of
- •transplant.
- •Patients with known HIV disease.
- •Patients with active systemic infection that requires continuing antibiotic
- •Patients with malignancy of any organ system, with the exception of localized
- •excised skin cancer.
- •Patients with severe anemia (hemoglobin <6g/dl), leukopenia (WBC <2500/mm3)
- •and/or thrombocitopenia (platelet count <80.000/mm3).
- •Hemodynamically unstable patients, even if they have hemoglobin levels> 6g /
- •Patients with intestinal pathology or severe diarrhea that may decrease
- •absorption according to medical criteria.
- •Patients with known hypersensitivity to any of the drugs used in this study.
- •Patients who have received any investigational drug in the 30 days prior to
- •their inclusion in this study.
- •Women of child-bearing potential who do not agree to use reliable
- •contraceptive measures during the trial, who are pregnant, breast-feeding or
- •presents a positive pregnancy test at the time of inclusion in the study.
- •Patients who are legally detained in an official institution.
研究者
相似试验
进行中（未招募）
1 期
Trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in patients with head and neck cancer undergoing radiotherapy.Patients with head and neck cancer .MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005110-30-ITFONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI158
进行中（未招募）
1 期
A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids.polmonite severa da coronavirus 2019MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-005291-35-ITAOU POLICLINICO DI MODENA640
招募中
1 期
A multicenter randomized trial to evaluate the efficacy of pioglitazone to improve renal outcome in ANCA-associated vasculitis - RENATOANCA-associated vasculitisCTIS2022-501057-36-00Assistance Publique Hopitaux De Paris126
招募中
1 期
eurofeedback with Gait imagery for PDParkinson DiseaseJPRN-jRCTs062220027Mihara Masahito50
已完成
不适用
Multicentric randomised trial concerning the effect of radiotherapy for painful heel spur with very low dosesPainful heel spurMusculoskeletal DiseasesMusculoskeletal painISRCTN94220918German Cooperative Group on Radiotherapy for Benign Diseases (GCGBD) (Germany)200