NCT00498160

Brief Summary

The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with kidney failure allowing a reduction or cessation of immune-suppressive therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
17.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

19.6 years

First QC Date

July 6, 2007

Last Update Submit

July 15, 2022

Conditions

Renal Failure

Keywords

Kidney transplantToleranceMarrow/stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Level of Donor Chimerism from Enriched Hematopoietic Stem Cell Engraftment

    Tests are done at key time points to monitor for donor chimerism by evaluating presence of bone marrow-derived hematopoietic stem cells.

    one month to three years

Study Arms (1)

Living or Deceased Donor Kidney Allograft

EXPERIMENTAL

Recipients with the need for a living kidney allograft are treated with an enriched hematopoetic stem cell infusion from the same living donor. Recipients with the need for a deceased donor kidney allograft are treated with an enriched hematopoetic stem cell infusion from the same deceased donor

Biological: Enriched Hematopoietic Stem Cell Infusion

Interventions

Enriched Hematopoietic Stem Cell InfusionBIOLOGICAL

Enriched Hematopoietic Stem Cell Infusion

Living or Deceased Donor Kidney Allograft

Eligibility Criteria

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

You may qualify if:

  • Patients must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
  • Patient is receiving first renal transplant
  • Patient is receiving a renal transplant only
  • The crossmatch is negative between donor and recipient
  • Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
  • Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period. As long as there is insurance or funding that will cover the cost of the transplant and any research related complications, it is not necessary for the subjects to be US citizens to participate in this trial.

You may not qualify if:

  • Clinically active bacterial, fungal, viral or parasitic infection
  • Pregnancy
  • Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
  • Previous radiation therapy at a dose which would preclude TBI
  • Positive crossmatch between donor and recipient
  • Evidence for immunologic memory against donor
  • BMI \>35 or \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

  • Senev A, Tambur AR, Kosmoliaptsis V, Copley HC, Garcia-Sanchez C, Usenko C, Ildstad ST, Leventhal JR. HLA molecular mismatches and induced donor-specific tolerance in combined living donor kidney and hematopoietic stem cell transplantation. Front Immunol. 2024 Mar 27;15:1377535. doi: 10.3389/fimmu.2024.1377535. eCollection 2024.

    PMID: 38601147DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Suzanne T Ildstad, MD

    Talaris Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

January 1, 2005

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

US(2)