EUCTR2021-000561-33-DE进行中（未招募）1 期
An open, randomized-controlled, multi-center phase-II clinical trial of individualized immunosuppression with intravenously administered donor modified immune cells (MIC) compared to standard-of-care in living donor kidney transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
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
- 性别
- All
入选标准
- •1. Age =18 years and able to consent
- •2. Ability to understand the nature and scope of the clinical trial
- •3. Written consent form given prior to any trial-related procedures (including PBMC donation)
- •1. Patient with CKD in stage 5 (e.g., estimated glomerular filtration rate [GFR] <15 mL/min and/or on renal replacement therapy), who are in preparation for kidney transplantation from a live donor
- •2. Age =18 years, <75 years
- •3. ABO-blood group identical or compatible with donor
- •4. First kidney transplantation
- •5. Complement dependent cytotoxicity (CDC)-panel reactive antibodies <20%
- •6. No detection of a donor-specific HLA-antibody in the Luminex-Assay (cutoff: mean fluorescence intensity [MFI] =1,000)
- •7. Negative CDC crossmatch with the donor
- •8. Negative PCR test result for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening
- •9. Patient’s living donor gave written consent for trial participation
- •10. Ability to understand the nature and scope of the clinical trial
- •11. Written informed consent given prior to any trial-related procedures
- •12. Female patients of childbearing potential must:
- •a. have a negative pregnancy test (blood) at Screening.
- •b. either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, 2 highly effective measures of contraception control (failure rate less than 1% per year when used consistently and correctly) without interruption, during the trial participation. Patients who discontinue mycophenolic acid derivate during the trial participation can switch to 1 highly effective contraceptive method 6 weeks after the end of mycophenolic acid derivative treatment. Reliable methods for this trial are: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence or vasectomized sexual partner. Abstinence from heterosexual contact is only accepted as true abstinence: when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal] is not an acceptable method of contraception.) Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile female patients (tubal ligation, hysterectomy or bilateral oophorectomy) may be enrolled.
- •c. agree to abstain from breast feeding during the trial participation.
- •13. Male patients must practice true abstinence or agree to use a condom during sexual contact with a pregnant woman or a woman of childbearing potential during the trial participation and for at least 90 days after the end of trial participationmycophenolic acid derivative treatment, even if he has undergone a successful vasectomy.
- •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 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Pregnant or breastfeeding
- •2. Participation in an interventional clinical trial within 30 days prior to Screening or in observation period of a competing study
- •3. Severe psychiatric disease
- •4. Severe cardiovascular diseases (i.e., heart insufficiency of grade NYHA III or IV)
- •5. Severe neurological diseases
- •6. Severe liver or kidney diseases
- •7. Any acute or chronic disease that may put the donor at risk in case of cell donation by leukapheresis
- •8. Malignant neoplasms, except in situ carcinoma after complete removal
- •9. Known infections or exposures to human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E virus, West e virus (WNV; testing only required during WNV season [June 1st to November 30th of a year]), gonorrhea or syphilis, with the risk of transmission of infection
- •10. Active bacterial, mycotic or viral infection
- •11. Known malaria infection; known infection of tuberculosis, Q fever, Salmonella typhi and paratyphi, or osteomyelitis (if not medically documented to have been cured for 2 years); known toxoplasmosis (except if symptom free for 6 months); after completion of treatment for rheumatic fever (except if treatment was completed for 2 years)
- •12. Known transmissible spongiform encephalopathies
- •13. Known protozoonosis (babesiosis, trypanosomiasis [e.g., chagas], leishmaniosis), known chronic bacterial infections as brucellosis, rickettsiosis, leprosy, relapsing fever, melioidosis, tularemia (except after assured healing according to documented medical assessment)
- •14. Autoimmune diseases requiring systemic immunosuppressive therapy
- •15. Allergies requiring systemic immunosuppressive therapy
- •16. Immunosuppressive therapy within 6 months prior screening
- •17. Known or suspected abuse of alcohol, drugs, or medicinal products
- •18. Unexplained night sweats, unexplained fever, unexplained weight loss, prolonged unexplained cough or diarrhea, unexplained skin lesions, lymph gland swelling or thrush
- •19. Dura mater and/or cornea grafts, allogeneic organ transplants, xenotransplants, pituitary hormones of human origin received
- •20. Stay of longer than 6 months in the United Kingdom between 1980 and 1996 and/or an operation and/or blood transfusion in the United Kingdom after 01-Jan 1980
- •21. Operations or other invasive interventions (e.g., endoscopies, biopsies, catheter applications, acupunctures [except acupuncture with sterile and/or disposable needles]) within 4 months prior to Screening
- •22. Any invasive exposure to blood (i.e., allogeneic blood components or plasma derivatives) or blood-contaminated injection needles or instruments, tattoos or piercings within 4 months prior to Screening
- •23. Positive PCR test result for SARS-CoV-2 at Screening
- •24. Hemoglobin <8.0 g/dL, thrombocytes <80,000/µL and/or leukocytes <3,000/µL
- •25. Known history of hypersensitivity to components used in the leukapheresis setting (i.e., components of the anticoagulant acid citrate dextrose solution)
- •26. Any finding or medical condition prohibiting the inclusion in the trial according to the judgment of the responsible leukapheresis physician
- •1. Preexisting severe psychiatric disorder
- •2. Heart insufficiency of grade NYHA III or IV
- •3. Severe liver disease (aspartate aminotransferase or alanine aminotransferase or gamma glutamyl transpeptidase =3 x ULN)
- •4. Active infection of HIV, HBV, HCV, EBV, or syphilis
- •5. Active bacterial, mycotic, or viral infection
- •6. Negative serological test result f
研究者
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