Yeni Böbrek Naklinde İmmünsüpresyonu Azaltmak İçin Vericiye Özgü T Hücre Yanıtının Prospektif Ölçümü

Sade dilde özet

Bu çalışma, ilk böbrek nakli (renal transplantation) yapılan hastalarda vericiye özgü T hücre yanıtının ölçülmesiyle bağışıklık baskılayıcı (immünsüpresif) ilaç dozunun azaltılıp azaltılamayacağını araştırmıştır. Hastalar Tacrolimus, mikofenolat mofetil (MMF) ve steroid tedavisi almış; çalışmaya 18 yaş ve üzeri, ilk kez böbrek nakli olan hastalar alınmıştır. Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

Prof. Dr. Petra Reinke

Müdahale

Tacrolimus (for Group B), MMF (mycophenolate mofetil) (for Group B), 6-methyl prednisolone (Steroids) (for Group B), Tacrolimus (for Group A), Mycofenolate mofetil (MMF) (for Group A), 6-methyl prednisolone (Steroids) (for Group A)

Başlangıç

01.03.2015

Tahmini bitiş

31.10.2020

Ülkeler

Czechia, France, Germany, Netherlands, Spain, United Kingdom

İlgili genler

Merkezler

• Prague, Czechia
• Nantes, France
• Berlin, Germany
• Hamburg, Germany
• Regensburg, Germany
• Amsterdam, Netherlands
• L'Hospitalet de Llobregat, Spain
• London, United Kingdom

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Men and women, age ≥18 years.
2. Subject must be a recipient of a first renal transplant from a deceased or living donor.
3. Subject must have a current documented PRA (Panel of reactive antibodies) \<20% and no detectable anti-class I and II HLA (human leukocyte Antigens) antibodies by solid phase assay (Luminex®).
4. Subject is willing to provide signed written informed consent.
5. Women of Childbearing Potential (WOCBP) must be using a highly effective method of contraception (Pearl-Index \< 1) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL\]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG (Human chorionic gonadotropin)) within 72 hours prior to the start of clinical trial.

Exclusion Criteria:

1. Subjects undergoing renal transplant with a current documented PRA \>20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
2. CDC (complement dependent cytotoxicity) positive cross match.
3. Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes.
4. Cold ischemia time (CIT) higher than 24h.
5. Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT.
6. Patients previously treated with daclizumab or basiliximab.
7. Subjects with underlying renal disease of:

   * Primary focal segmental glomerulosclerosis.
   * Type I or II membranoproliferative glomerulonephritis
   * Atypical Haemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura syndrome.
8. Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive PCR (polymerase chain reaction result) at the moment of transplant.
9. Subjects with known human immunodeficiency virus (HIV) infection.
10. Patients with active systemic infection that requires the continued use of antibiotics.
11. Patients with neoplasia except localized skin cancer receiving appropriate treatment.
12. Patients with severe anemia (hemoglobin \< 6g/dl), leucopenia (WBC (White blood cells) \<2500/mm3), thrombocytopenia (platelets \<80.000/mm3).
13. Hemodynamically instable patients even if their hemoglobin level counts \> 6 g/dl.
14. Patients with intestinal pathology or severe diarrhoea that can hinder absorption according to medical criteria.
15. Subjects with a known hypersensibility to any of the drugs used in this protocol.
16. Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial.
17. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
18. Subjects who are legally detained in an official institution