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Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.

ConditionImmune Tolerance
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStephan Busque

About this trial

The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.

Patients who agree to participate in the study and sign an Informed Consent

The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.

The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.

Disqualifiers

Known allergy to ATG or a known allergy to rabbit proteins.

History of malignancy with the exception of non-melanoma skin malignancies.

Pregnant women or nursing mothers.

Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hematopoietic cell transplantation

    Biological/Vaccine

    Transplantation of hematopoietic stem cells from living donor.

  • Total Lymphoid irradiation

    Radiation

    Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Immune tolerance, Kidney transplantationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of patients no longer dependent on immunosuppressive drugs to maintain normal renal function.

A patient will be considered no longer dependent if able to maintain normal renal function after coming off immunosuppressive medications.

Time frame
six months to up to five years post stem cell transplant

Secondary outcomes

1

Percentage of patients experiencing biopsy proven rejection episodes requiring treatment requiring corticosteroids.

Time frame
One year to five years
2

Percentage of patients experiencing graft loss.

Time frame
One year to five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephan Busque

Lead sponsor

Stanford University

Sponsor institution

Source ClinicalTrials.gov
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