Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-000785
    • Jacksonville, Florida: 18-000785
    • Scottsdale/Phoenix, Arizona: 18-000785
    NCT ID: NCT03363945
    Sponsor Protocol Number: MDR-101-MLK

About this study

The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Recipient Inclusion Criteria:

  • Planned recipient of a first kidney allograft from an HLA-matched, living related donor
  • Age ≥18 and ≤65 years
  • Single solid organ recipient (kidney only)
  • ABO compatibility with donor

Recipient Exclusion Criteria:

  • Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
  • Baseline positive donor-specific anti-HLA antibody testing
  • Is taking immunosuppressive therapy
  • Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)

Donor Inclusion Criteria:

  • HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling) relative of the prospective recipient participant
  • Age ≥18 and ≤65 years
  • Prepared to be a living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells

Donor Exclusion Criteria:

  • History of autoimmune disorders
  • History of type 1 or type 2 diabetes mellitus
  • Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
  • History of infection with Zika virus

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Nong Braaten

(507)538-9617

Braaten.Nong@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Contact us for the latest status

Contact information:

Joel Espinoza

(904)953-8855

Espinoza.Joel@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available