Kidney Transplantation Clinical Trial
Official title:
Impact of Rituximab Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation - a Prospective Pilot Study
Verified date | October 2019 |
Source | University of Giessen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project comprises immunological and virological analyses within a prospective clinical study of Rituximab (Rtx)-treated blood group incompatible living donor (LD) renal transplant recipients compared to blood group compatible LD recipients without Rtx induction, and of living donor compared to deceased donor renal transplant recipients treated with tacrolimus (Tacr)/mycophenolate sodium (MPS). Aim of this project is to assess short- and long-term effects of immunosuppressive therapy (Rtx induction) and of living donation on immunological and histological parameters of graft outcome and on viral replication (BK virus (BKV), JC virus (JCV), cytomegalovirus (CMV), Epstein Barr virus (EBV)) with the potential to improve long-term graft outcome and to enable risk estimation of virus disease.
Status | Completed |
Enrollment | 85 |
Est. completion date | June 18, 2019 |
Est. primary completion date | June 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - De-novo kidney transplantation - Deceased donors (blood group compatible) and living donors (blood group incompatible / blood group compatible) - First, second and third renal transplants - Immunized and non-immunized graft recipients - Age of recipients 18 years or older - Negative pregnancy test before transplantation Exclusion Criteria: - Contra-indications to use Tacr and MPS, respectively - Contra-indications to use Rtx in the group of ABOi LD transplants - Chronic hepatitis B, C or HIV infection - Recurrent infectious disease - Previous hepatitis B, if no prophylactic antiviral therapy is used - Previous tuberculosis - Hemoglobin<8,5g/dl, thrombocytes<80.000/ul or leucocytes<3000/ul - Previous vaccination with a living vaccine <4 weeks pretransplant - Significant enterogastric disease such as diverticulitis (contra-indicates MPS treatment) - Children and adolescents (age less than 18 years) - Pregnancy and breast-feeding women - Refusal of an effective contraception in women capable of bearing children - Combined transplantations such as simultaneous islet/kidney transplants |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Internal Medicine, University of Giessen | Giessen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen | Astellas Pharma US, Inc., German Cancer Research Center, Heidelberg University, Novartis |
Germany,
Daniel V, Naujokat C, Sadeghi M, Renner FC, Weimer R, Opelz G. Association of high IFN-gamma plasma levels with low B-cell counts in renal transplant recipients with stable long-term graft function. Clin Transplant. 2010 Mar-Apr;24(2):281-9. doi: 10.1111/j.1399-0012.2009.01067.x. Epub 2009 Aug 27. — View Citation
Hackstein H, Renner FC, Bohnert A, Nockher A, Frommer T, Bein G, Weimer R. Dendritic cell deficiency in the blood of kidney transplant patients on long-term immunosuppression: results of a prospective matched-cohort study. Am J Transplant. 2005 Dec;5(12):2945-53. — View Citation
Sadeghi M, Daniel V, Weimer R, Wiesel M, Hergesell O, Opelz G. Differential early posttransplant cytokine responses in living and cadaver donor renal allografts. Transplantation. 2003 Apr 27;75(8):1351-5. — View Citation
Staak A, Renner F, Suesal C, Dietrich H, Rainer L, Kamali-Ernst S, Ernst W, Padberg W, Opelz G, Weimer R. Immunoglobulin induction therapy in renal transplant recipients: Effects on immunoglobulin and regulatory antibody levels. Transplant Proc. 2006 Dec;38(10):3483-5. — View Citation
Süsal C, Döhler B, Opelz G. Graft-protective role of high pretransplantation IgA-anti-Fab autoantibodies: confirmatory evidence obtained in more than 4000 kidney transplants. The Collaborative Transplant Study. Transplantation. 2000 Apr 15;69(7):1337-40. — View Citation
Süsal C, Pelzl S, Döhler B, Opelz G. Identification of highly responsive kidney transplant recipients using pretransplant soluble CD30. J Am Soc Nephrol. 2002 Jun;13(6):1650-6. — View Citation
Weimer R, Melk A, Daniel V, Friemann S, Padberg W, Opelz G. Switch from cyclosporine A to tacrolimus in renal transplant recipients: impact on Th1, Th2, and monokine responses. Hum Immunol. 2000 Sep;61(9):884-97. — View Citation
Weimer R, Mytilineos J, Feustel A, Preiss A, Daniel V, Grimm H, Wiesel M, Opelz G. Mycophenolate mofetil-based immunosuppression and cytokine genotypes: effects on monokine secretion and antigen presentation in long-term renal transplant recipients. Transplantation. 2003 Jun 27;75(12):2090-9. — View Citation
Weimer R, Staak A, Süsal C, Streller S, Yildiz S, Pelzl S, Renner F, Dietrich H, Daniel V, Rainer L, Kamali-Ernst S, Ernst W, Padberg W, Opelz G. ATG induction therapy: long-term effects on Th1 but not on Th2 responses. Transpl Int. 2005 Feb;18(2):226-36. — View Citation
Weimer R, Süsal C, Yildiz S, Staak A, Pelzl S, Renner F, Dietrich H, Daniel V, Kamali-Ernst S, Ernst W, Padberg W, Opelz G. Post-transplant sCD30 and neopterin as predictors of chronic allograft nephropathy: impact of different immunosuppressive regimens. Am J Transplant. 2006 Aug;6(8):1865-74. Epub 2006 Jun 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of Rtx on immune parameters predictive of graft outcome including B cell responses | immune parameters of graft outcome: see "detailed description" | 5 years posttransplant | |
Primary | Impact of living donation on immune parameters predictive of graft outcome including B cell responses | parameters of graft outcome: see "detailed description" | 5 years posttransplant | |
Primary | Impact of Rtx on virus replication | outcome measure description: EBV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of Rtx on virus replication | outcome measure description: CMV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of Rtx on virus replication | outcome measure description: BKV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of Rtx on virus replication | outcome measure description: BKV PCR (in urine) | 5 years posttransplant | |
Primary | Impact of Rtx on virus replication | outcome measure description: JCV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of Rtx on virus replication | outcome measure description: JCV PCR (in urine) | 5 years posttransplant | |
Primary | Impact of living donation on virus replication | outcome measure description: EBV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of living donation on virus replication | outcome measure description: CMV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of living donation on virus replication | outcome measure description: BKV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of living donation on virus replication | outcome measure description: BKV PCR (in urine) | 5 years posttransplant | |
Primary | Impact of living donation on virus replication | outcome measure description: JCV PCR (in blood) | 5 years posttransplant | |
Primary | Impact of living donation on virus replication | outcome measure description: JCV PCR (in urine) | 5 years posttransplant | |
Secondary | Patient survival | patient survival 5 years posttransplant will be analyzed | 5 years posttransplant | |
Secondary | Graft survival | Graft survival 5 years posttransplant will be analyzed | 5 years posttransplant | |
Secondary | Graft function and proteinuria | 5-year graft function will be analyzed by serum creatinine and measured creatinine clearance, proteinuria by proteinuria within a 24h urine collection period | 5 years posttransplant | |
Secondary | Graft function | 5-year graft function will be analyzed by serum creatinine and measured creatinine clearance, proteinuria by proteinuria within a 24h urine collection period | 5 years posttransplant | |
Secondary | Graft function | 5-year graft function will be analyzed by measured creatinine clearance | 5 years posttransplant | |
Secondary | Proteinuria | 5-year proteinuria will be analyzed urine collected 24 hours | 5 years posttransplant | |
Secondary | Incidence of acute rejection | incidence of biopsy proven acute rejection within 1 year posttransplant will be analyzed | 1 year posttransplant | |
Secondary | Incidence of acute rejection | incidence of biopsy proven acute rejection within 2 years posttransplant will be analyzed | 2 years posttransplant | |
Secondary | Incidence of acute rejection | incidence of biopsy proven acute rejection within 5 years posttransplant will be analyzed | 5 years posttransplant | |
Secondary | Incidence of chronic allograft dysfunction | Chronic allograft dysfunction (progressive decline of graft function) will be analyzed at 5 years posttransplant. | 5 years posttransplant | |
Secondary | Incidence of severe infectious disease | severe infectious disease as defined by need for in-hospital treatment | 5 years posttransplant | |
Secondary | Incidence of malignancy | all types of malignancies within 5 years posttransplant will be evaluated | 5 years posttransplant | |
Secondary | Incidence of side effects associated with Rtx | all side effects of Rtx treatment which have been described in literature, will be listed | 5 years posttransplant |
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