NL-OMON45007已完成4 期
Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI).;Open randomized 12 month study. - Nulojix study
niversity Hospital Uppsala0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 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 64（—）
入选标准
- •1. Signed Written Informed Consent
- •2. Target Population:
- •2.a Renal transplant recipients of living donor or deceased donor kidney transplant.
- •2.b Stable renal graft (eGFR > 20 ml/min) with no need for exploratory examination)
- •2.c Tacrolimus or CsA (Cyclosporine A) standard treatment since transplantation
- •2.d 3 * 60 months post-transplantation at randomization
- •3. Age and Sex:
- •3.a Men and women, aged 18 to 80 years, both inclusive
- •3.b Women of childbearing potential (WOCBP) must be using adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy. WOCBP 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. Post-menopause is defined as:
- •*Amenorrhea that has lasted for 12 consecutive months without another cause, or
- •*For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
- •Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (e.g. vasectomy) should be considered to be of childbearing potential.
- •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product (belatacept).
排除标准
- •1. Sex and Reproductive Status:
- •1.a Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug.
- •1.b Women who are pregnant or breastfeeding.
- •1.c Women with a positive pregnancy test.
- •2. Target Disease Exceptions: Subjects who are Epstein-Barr virus IgG negative or have unknown IgG status for EBV.
- •3. Medical History and Concurrent Diseases:
- •3.a De novo or recurrent underlying renal disease that, in the investigator's opinion, could adversely influence the current allograft
- •3.b History of vascular or antibody-mediated rejection in the present transplant
- •3.c Ongoing serious infections, as per investigator's opinion
- •3.d Signs of post-transplant lymphoproliferative disorder
- •3.e History of tuberculosis. If the patient has a history of active TB or a history of latent untreated TB, the patient must be excluded from the study. If the patient has a history of latent treated TB, the patient can be included.
- •3.f Signs of malignancy. Exceptions are BCC/SCC or non-malignant melanoma
- •3.g History of malignancy, unless subject has been considered to have fully recovered from malignancy since >1 year, without any signs of relapse
- •3.h Life expectancy < 3 years at the time of randomization
- •4. Allergies and Adverse Drug Reactions:
- •4.a Hypersensitivity to belatacept
- •4.b Previous/ongoing use of rituximab in connection with the current transplant.
- •5. Other Exclusion Criteria:
- •5.a Prisoners, or subjects who are involuntarily incarcerated.
- •5.b Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
研究者
相似试验
进行中（未招募）
1 期
Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI)Open randomized 12 month studyEUCTR2013-001178-20-SEppsala University Hospital, MHT, Department of Nephrology105
进行中（未招募）
1 期
Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI)Open randomized 12 month studyProphylaxis of graft rejection in adults who have received a renal transplantMedDRA version: 20.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000022818EUCTR2013-001178-20-DKppsala University Hospital, MHT, Department of Nephrology110
进行中（未招募）
1 期
Does conversion to Nulojix reduce the risk of cardiovascular disease in kidney transplant recipients?Prophylaxis of graft rejection in adults who have received a renal transplantMedDRA version: 17.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865EUCTR2013-001178-20-NLppsale University Hospital, MHT, Department of Nephrology105
尚未招募
Unknown
cardiovascular risk prediction as per prakritiCTRI/2024/05/067087Chaudhary Brahm Prakash ayurved Charak Sansthan
招募中
4 期
A clinical trial for Heart Disease Risk assessment and treatment of patients with high risk.CTRI/2019/04/018723Dr Saurabha Nayak