EUCTR2013-002090-21-DE进行中（未招募）1 期
Evaluation of Acute Rejection Rates in de novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (belatacept) -based Immunosuppression
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •Signed Written informed Consent, the subject or legal representative is
- •willing to provide signed written informed consent. Adults with endstage renal disease (ESRD) scheduled to undergo transplantation of a non-HLA identical, living or standard criteria deceased (SCD) donor
- •kidney; Subjects with serological evidence of prior exposure to EBV.
- •Evidence of prior exposure is to be determined locally by positive testing
- •for IgG antibodies directed against EBV firal capsid antigen (VCA) and Epstein-Barr nuclear antigen (EBNA). Historical results are acceptable. •
- •Men and women, 18to 75 at Screening, inclusive; Women of childbearing
- •potential (WOCBP) must use highly effective methods of birth control to
- •avoid pregnancy throughout the study and for up to 8 weeks after the
- •study in such a manner that the risk of pregnancy is minimized;
- •Acceptable methods of highly effective birth control include: Condom
- •with spermicide, Diaphragm and spermicide, Cervical cap and
- •spermicide, Oral contraceptives, Intrauterine device (IUD); It should be
- •noted that according to the US product information for mycophenolate
- •mofetil (CellCept®), two reliable forms of contraception must be used
- •simultaneously unless abstinence is the chosen method; WOCBP must
- •have a negative serum or urine pregnancy test (minimum sensitivity 25
- •IU/L or equivalent units of beta-human chorionic gonadotropin [ß-HCG])
- •within 24 hours prior to the start of study medication; Women must not
- •be breastfeeding; Sexually active fertile men must use highly effective
- •birth control if their partners are WOCBP. Men who are sexually active
- •with WOCBP must follow instructions for birth control for the entire
- •duration of the study and a minimum of 8 weeks post study drug has
- •been completed; Women who are not of childbearing potential (ie, who
- •are postmenopausal or surgically sterile; see Section 3.3.3 for the
- •definition of WOCBP) and azoospermic men do not require
- •contraception.
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •Subjects who are seronegative for prior exposure to EBV or those whose EBV serologic status is unknown at randomization. Genetically-identical donor recipient pairs (ie, identical twins) Subjects with a recent (within 3 months prior to transplant) PRA more than or equal to 20%. Subjects with a past history of, or current need for desensitization therapy. Subjects with previous graft loss due to acute rejection Subjects with a positive T-cell or lymphocytotoxic cross match or any detectable donor specific antibodies prior to transplantation. Recipients of kidneys from donors < 10 years old. Recipients of an extended criteria deceased donor (ECD) kidney, defined as: -Donors more than or equal to 60 years old, or -Donors aged 50 – 59 years with any 2 of the following: death from cerebrovascular accident; hypertension; serum creatinine > 1.5 mg/dL;or -Recipients of kidneys donated after cardiac death. Subjects with prior or concurrent non-renal solid organ or cell (eg, pancreas or kidneypancreas, islet transplant or stem-cell) transplants and those deemed by the Investigator as being likely to require a non-renal transplant in the
- •next 3 years.Subjects receiving paired (dual or en bloc kidney
- •transplants). CMV negative subjects scheduled to receive a kidney from
- •a CMV positive donor. Subjects with ESDR due to any of the following underlying conditions : primary focal segmental glomerulosclerosis, type I or II membranoproliferative glomerulonephritis,hemolytic uremic syndrome/Thrombotic Thrombocytopenic Purpura Hepatitis C virus (HCV): subjects or donors known to be positive for anti-HCV antibody or for HCV RNA detectable by polymerase chain reaction (PCR). Hepatitis B virus (HBV): subjects or donors known to be positive for hepatitis B surface antigen or for HBV DNA detectable PCR. Human immunodeficiency virus (HIV): subjects or donors known to be HIV positive. Subjects with current evidence or past history of active or inadequately treated latent TB infection: Subjects must have documentation of a chest x-ray (posterior-anterior and lateral views) that is negative for radiographic evidence of pulmonary TB within
- •the last 6 months prior to transplant.A negative screening test for latent TB infection (LTBI) [intradermal PPD, or interferon-gamma release assay (IGRA) such as QuantiFERON TB Gold test or T-Spot-TB] that was performed at any time prior to the current transplant. Those subjects who do not have documented negative result specifically from an IGRA test performed within the last 3 months prior to randomization, must be screened for latent TB with an Interferon gamma release assay (IGRA) test performed during the Screening visit- TB. Results of IGRA are not required for randomization when the results from a historical negative screening test (PPD or IGRA) are available. If equipment for sample preparation prior to shipment to central lab is not available at the site, a local lab IGRA test is acceptable. If a historical negative screening test (PPD or IGRA) result for LTBI was available and the patient was randomized on that basis, but the Screening Visit IGRA is subsequently reported (post-transplant) to be positive, treatment for latent TB must be initiated upon receipt of the test result by the Investigator. Treatment may consist of isoniazid (INH, isonicotinic acid hydrazide), 300 mg p.o. once daily for 9 months or an alternative that is consistent with the local standard of care. History of biopsy-confirmed malignancy (other
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