NCT02560220

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

August 6, 2015

Last Update Submit

July 23, 2018

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.

    30 days

Secondary Outcomes (10)

  • Cumulative incidence of infection

    30 days

  • Cumulative incidence of CMV reactivation

    30 days

  • Number of patients with PTLD

    30 days

  • Number of patients with delayed graft function

    7 days

  • Number of patients with a pos. CDC and/or ELISA crossmatch

    day -1 before transplantation

  • +5 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

Patients receive MIC cell therapy together with standard immunosuppressive therapy

Biological: Mitomycin C-induced peripheral blood mononuclear cells (MICs)

Interventions

Mitomycin C-induced peripheral blood mononuclear cells (MICs)BIOLOGICAL

MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (7)

  • 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.

    PMID: 26077202BACKGROUND

  • 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.

    PMID: 25495457BACKGROUND

  • 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.

    PMID: 26074415BACKGROUND

  • Terness P, Oelert T, Ehser S, Chuang JJ, Lahdou I, Kleist C, Velten F, Hammerling 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.

    PMID: 19017789BACKGROUND

  • Schaier M, Morath C, Wang L, Kleist C, Opelz G, Tran TH, Scherer S, Pham L, Ekpoom N, Susal C, Ponath G, Kalble F, Speer C, Benning L, Nusshag C, Mahler CF, Pego da Silva L, Sommerer C, Huckelhoven-Krauss A, Czock D, Mehrabi A, Schwab C, Waldherr R, Schnitzler P, Merle U, Schwenger V, Krautter M, Kemmner S, Fischereder M, Stangl M, Hauser IA, Kalsch AI, Kramer BK, Bohmig GA, Muller-Tidow C, Reiser J, Zeier M, Schmitt M, Terness P, Schmitt A, Daniel V. Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation. Front Immunol. 2023 Jul 11;14:1089664. doi: 10.3389/fimmu.2023.1089664. eCollection 2023.

    PMID: 37483623DERIVED

  • Morath C, Schaier M, Ibrahim E, Wang L, Kleist C, Opelz G, Susal C, Ponath G, Aly M, Alvarez CM, Kalble F, Speer C, Benning L, Nusshag C, Pego da Silva L, Sommerer C, Huckelhoven-Krauss A, Czock D, Mehrabi A, Schwab C, Waldherr R, Schnitzler P, Merle U, Tran TH, Scherer S, Bohmig GA, Muller-Tidow C, Reiser J, Zeier M, Schmitt M, Terness P, Schmitt A, Daniel V. Induction of Long-Lasting Regulatory B Lymphocytes by Modified Immune Cells in Kidney Transplant Recipients. J Am Soc Nephrol. 2023 Jan 1;34(1):160-174. doi: 10.1681/ASN.2022020210. Epub 2022 Sep 22.

    PMID: 36137752DERIVED

  • Morath C, Schmitt A, Kleist C, Daniel V, Opelz G, Susal C, Ibrahim E, Kalble F, Speer C, Nusshag C, Pego da Silva L, Sommerer C, Wang L, Ni M, Huckelhoven-Krauss A, Czock D, Merle U, Mehrabi A, Sander A, Hackbusch M, Eckert C, Waldherr R, Schnitzler P, Muller-Tidow C, Hoheisel JD, Mustafa SA, Alhamdani MS, Bauer AS, Reiser J, Zeier M, Schmitt M, Schaier M, Terness P. Phase I trial of donor-derived modified immune cell infusion in kidney transplantation. J Clin Invest. 2020 May 1;130(5):2364-2376. doi: 10.1172/JCI133595.

    PMID: 31990685DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Zeier, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Martin Zeier, M. D.

Study Record Dates

First Submitted

August 6, 2015

First Posted

September 25, 2015

Study Start

August 5, 2015

Primary Completion

April 18, 2017

Study Completion

April 18, 2017

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

DE(1)