Skip to main content
OpenTrials
Completed

NCT Number: NCT02560220

MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitomycin C-induced peripheral blood mononuclear cells (MICs)

Biological

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

Primary outcomes

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

    Time frame: 30 days

Secondary outcomes

  1. Cumulative incidence of infection

    Time frame: 30 days

  2. Cumulative incidence of CMV reactivation

    Time frame: 30 days

  3. Number of patients with PTLD

    Time frame: 30 days

  4. Number of patients with delayed graft function

    Time frame: 7 days

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

    Time frame: day -1 before transplantation

  6. Number of patients with DSA

    Time frame: day -1 before transplantation and day 7 and 30 after transplantation

  7. Incidence of biopsy-proven cellular rejection

    Time frame: 30 days

  8. Incidence of biopsy-proven antibody-mediated rejection

    Time frame: 30 days

  9. Number of patients with stable graft function (S-creatinine < 2mg/dL)

    Time frame: 30 days

  10. Patient and graft survival

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • German Federal Ministry of Economics and Technology
  • WiSP GmbH

Registry information

Official study 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)

Acronym: TOL-1

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2015
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.