AzTrials
AzTrials

Immune TolerancePhase 1NCT04571203

Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment

A Phase 1 study testing Combined Deceased Donor Kidney and Hematopoietic Cell Transplants in people with Immune Tolerance, run by Stanford University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Immune Tolerance
What is being tested?
Combined Deceased Donor Kidney and Hematopoietic Cell Transplants
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
6 May 2022to 1 Oct 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • RECIPIENT INCLUSION CRITERIA:
  • Patient is ≥ 18 years old, and <65 years of age.
  • Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.
  • Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.
  • A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.
  • Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.
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  • Females have a negative serum pregnancy test.
  • Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.
  • No known contraindication to administration of rabbit ATG or low dose irradiation.
  • DONOR INCLUSION CRITERIA:
  • Brain dead donor aged ≥ 16 and ≤ 55
  • Organ Procurement Organization (OPO) consent for vertebral body procurement
  • Organ Procurement Organization consent for research
  • Projected cold ischemia time <24 hours.

Who cannot join

  • RECIPIENT EXCLUSION CRITERIA:
  • Known allergy to rabbit protein.
  • History of malignancy with the exception of non melanoma skin malignancy.
  • Pregnant woman or nursing mother.
  • Body weight >90kg or BMI >35.
  • Evidence of HIV 1/2 antibody (Ab), HTLV 1 and HTLV 2 Ab (Human T-Lymphotropic Virus), Hepatitis B sAg (surface antigen), Hepatitis C Ab, or positive syphilis screen.
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  • EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient.
  • Active bacterial, viral or fungal infection defined as currently taking medication for the infection.
  • Leukopenia (white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
  • Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk.
  • Concern for alcohol or other substance abuse.
  • Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy
  • Panel reactive antibody (PRA) >80%.
  • Positive donor specific antibody (DSA).
  • Prior or combined organ transplant.
  • Patients with >5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer.
  • DONOR EXCLUSION CRITERIA:
  • History of malignancy with the exception of non melanoma skin malignancy.
  • History of autoimmune disease.
  • Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening.
  • Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection.
  • Evidence of systemic infection.
  • Kidney Donor Profile Index (KDPI) > 70%.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carlos Lazarte, B.A. contact

6505548610

lazarte6@stanford.edu

Anika Tahsin, BS contact

atahsin@stanford.edu

United States2 sites, 2 recruiting

  • Stanford University

    Palo Alto, California, 94305

    Recruiting

  • MSOB

    Stanford, California, 94305

    Carlos Lazarte, BA, 6505548610, lazarte6@stanford.edu

    Anika Tahsin, BS, atahsin2@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase I Study of Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment

This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.

Read the detailed description

Patients will undergo a standard of care deceased donor kidney transplant and thereafter the recipient will receive TLI (Total Lymphoid Irradiation)/single low dose Total Body Irradiation, ATG (Anti-Thymocyte Globulin) conditioning, followed by an infusion of whole bone marrow cells harvested from the same donor vertebral bodies. Patients will be receive standard of care doses of steroids, MMF and tacrolimus as part of their transplant immunosuppression.

Subjects will be withdrawn from the immunosuppression if they have met the withdrawal criteria.

Being tested
Combined Deceased Donor Kidney and Hematopoietic Cell Transplants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Deceased Donor Kidney and Hematopoietic Cell TransplantsBiological

    Also called Radiation

    This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.

Study groups in NCT04571203
Study groupRoleWhat they receive
Phase I Study of Combined DD Kidney and HCT TransplantExperimentalSingle arm Phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion
Receives: Biological: Combined Deceased Donor Kidney and Hematopoietic Cell Transplants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor.

    Measured: 6 months

  2. Determine the dose of TBI that will support donor CD3 Tcell chimerism between 30-75% at 45 days post infusion

    TBI dose in cGy associated with donor Tcell chimerism of >30 % immunosuppressive drug monotherapy.

    Measured: day 45

Secondary outcomes (7)

  1. Number of patients who develop GVHD, all grades and types, within 60 months of kidney transplant

    Measured: 60 months

  2. Number of patients with either bacterial, viral or fungal infection within 12 months post transplant .

    Measured: 12 months

  3. Serum Creatinine

    Measured: up to 60 months

  4. Panel-Reactive Antibody (PRA)

    Report % of PRA on all participants

    Measured: Baseline, month 9, and month 12

  5. Donor-Specific Antibody (DSA)

    Report percentage of patients that develop DSA

    Measured: Baseline, month 9, and month 12

  6. Percentage of subjects on immunosuppressive medications after an eighteen month post transplant till month 60.

    Measured: 60 months

  7. Persistence of donor chimerism >1%

    Percentage of patients with donor chimerism (any lineage)

    Measured: 3,6,9,12,15,18,24,48,60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start6 May 2022
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
End Stage Renal Disease subjects will receive a deceased donor kidney and vertebral body stem cell infusion. These transplant recipients post kidney transplant will undergo conditioning by ATG, Total Lymphoid irradiation and 1 single dose of TBI. Subsequently, the vertebral body stem cell infusion will be administered.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571203
Sponsor's protocol ID
57511
Status last verified
Jun 2026
First submitted
17 Sep 2020
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Busque S, Scandling JD, Lowsky R, Shizuru J, Jensen K, Waters J, Wu HH, Sheehan K, Shori A, Choi O, Pham T, Fernandez Vina MA, Hoppe R, Tamaresis J, Lavori P, Engleman EG, Meyer E, Strober S. Mixed chimerism and acceptance of kidney transplants after immunosuppressive drug withdrawal. Sci Transl Med. 2020 Jan 29;12(528):eaax8863. doi: 10.1126/scitranslmed.aax8863.

    PubMed 31996467

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Combined Deceased Donor Kidney and Hematopoietic Cell Transplants in people with Immune Tolerance, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carlos Lazarte, B.A. (6505548610, lazarte6@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04571203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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