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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2018
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Mitomycin C-induced peripheral blood mononuclear cells (MICs)
MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor

Locations

Country Name City State
Germany University of Heidelberg Heidelberg Baden-Wuerttemberg

Sponsors (3)

Lead Sponsor Collaborator
Heidelberg University German Federal Ministry of Economics and Technology, WiSP GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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

Outcome

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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