Kidney Failure, Chronic Clinical Trial
— TOL-1Official title:
A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)
NCT number | NCT02560220 |
Other study ID # | TOL-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | August 5, 2015 |
Est. completion date | April 18, 2017 |
Verified date | July 2018 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or < 15 mL/min) who receive a kidney transplant from a living donor.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 18, 2017 |
Est. primary completion date | April 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic kidney disease stage KDIGO 4 or 5 - First kidney transplant from a living donor - Age = 18 years - ABO compatible - CDC-PRA < 20% - No donor-specific antibodies - Negative CDC and ELISA crossmatch - Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone - Informed consent - Adequate contraception (women with child bearing potential) Exclusion Criteria: - Psychiatric disorder - Heart failure (NYHA III or IV) - Severe liver disease - Active hepatitis B or C or HIV infection - Active bacterial, fungal or viral disease - Malignancy or malignancy in the last 5 years before screening - Preexisting immunosuppression - Vaccination with a live vaccine in the last 3 months before screening - S/p splenectomy - Substance abuse - Pregnancy or lactation - Women: Child/pregnancy with the intended donor - Allergy against the investigational drug or part of it - Other diseases that prohibit participation in the study (in the opinion of the investigator) - Participation in an other interventional study |
Country | Name | City | State |
---|---|---|---|
Germany | University of Heidelberg | Heidelberg | Baden-Wuerttemberg |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University | German Federal Ministry of Economics and Technology, WiSP GmbH |
Germany,
Dittmar L, Mohr E, Kleist C, Ehser S, Demirdizen H, Sandra-Petrescu F, Hundemer M, Opelz G, Terness P. Immunosuppressive properties of mitomycin C-incubated human myeloid blood cells (MIC) in vitro. Hum Immunol. 2015 Jul;76(7):480-7. doi: 10.1016/j.humimm.2015.06.008. Epub 2015 Jun 11. — View Citation
Kleist C, Sandra-Petrescu F, Jiga L, Dittmar L, Mohr E, Greil J, Mier W, Becker LE, Lang P, Opelz G, Terness P. Generation of suppressive blood cells for control of allograft rejection. Clin Sci (Lond). 2015 May;128(9):593-607. doi: 10.1042/CS20140258. — View Citation
Morath C, Schmitt A, Zeier M, Schmitt M, Sandra-Petrescu F, Opelz G, Terness P, Schaier M, Kleist C. Cell therapy for immunosuppression after kidney transplantation. Langenbecks Arch Surg. 2015 Jul;400(5):541-50. doi: 10.1007/s00423-015-1313-z. Epub 2015 Jun 17. Review. — View Citation
Terness P, Oelert T, Ehser S, Chuang JJ, Lahdou I, Kleist C, Velten F, Hämmerling GJ, Arnold B, Opelz G. Mitomycin C-treated dendritic cells inactivate autoreactive T cells: toward the development of a tolerogenic vaccine in autoimmune diseases. Proc Natl Acad Sci U S A. 2008 Nov 25;105(47):18442-7. doi: 10.1073/pnas.0807185105. Epub 2008 Nov 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation. | 30 days | ||
Secondary | Cumulative incidence of infection | 30 days | ||
Secondary | Cumulative incidence of CMV reactivation | 30 days | ||
Secondary | Number of patients with PTLD | 30 days | ||
Secondary | Number of patients with delayed graft function | 7 days | ||
Secondary | Number of patients with a pos. CDC and/or ELISA crossmatch | day -1 before transplantation | ||
Secondary | Number of patients with DSA | day -1 before transplantation and day 7 and 30 after transplantation | ||
Secondary | Incidence of biopsy-proven cellular rejection | 30 days | ||
Secondary | Incidence of biopsy-proven antibody-mediated rejection | 30 days | ||
Secondary | Number of patients with stable graft function (S-creatinine < 2mg/dL) | 30 days | ||
Secondary | Patient and graft survival | 30 days |
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