Kidney FailurePhase 2NCT00497926
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
A Phase 2 study testing Enriched Hematopoietic Stem Cell Infusion in people with Kidney Failure, run by Talaris Therapeutics Inc. at 2 sites in United States.
Trial summary
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Enriched Hematopoietic Stem Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
- Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation
- Patient is receiving a renal transplant only
- The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis.
- Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion
- Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF
Show all 9Show fewer
- No evidence of donor-specific antibody presently or historically
- Panel Reactive Antibody (PRA) less than or equal to 20
- 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 month of the protocol so that they can be monitored closely in the early post-transplant period.
Who cannot join
- 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 or FCRx infusion
- Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)
- Positive crossmatch between donor and recipient
- Evidence for immunologic memory against donor
- Body Mass Index (BMI) >35 or <18
- Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), human immunodeficiency virus (HIV)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
About this study
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
Read the detailed description
Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
- Conditions
- Kidney Failure
- Being tested
- Enriched Hematopoietic Stem Cell Infusion
- Keywords
- Kidney transplant, Tolerance, Marrow/Enriched Hematopoietic Stem Cell Transplant
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Hematopoietic Stem Cell InfusionBiological
Enriched Hematopoietic Stem Cell Infusion
| Study group | Role | What they receive |
|---|---|---|
| Living Kidney Allograft | Experimental | Recipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor Receives: Biological: Enriched Hematopoietic Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enriched Hematopoietic Stem Cell Engraftment
Measured: One month to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startMar 2008
- Primary completionMar 2023
- Study completionApr 2023
Why it stopped: living donor kidney program terminated due to slow pace of phase 3 study enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talaris Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University, Regenerex, LLC, Duke University
- Responsible party
- Sponsor
- Investigators
- Ken Abrams, MD, Study director, Talaris Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497926
- Sponsor's protocol ID
- FCR001A2201
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2007
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leventhal JR, Galvin J, Ison MG, Feng CY, Ding R, Lee JR, Li C, Mathew JM, Gallon L, Gibson M, Belshe D, Tollerud DJ, Gornstein E, Suthanthiran M, Ildstad ST. Evaluation of Immunocompetence and Biomarkers of Tolerance in Chimeric and Immunosuppression-free Kidney Allograft Recipients. Transplantation. 2023 Oct 1;107(10):e257-e268. doi: 10.1097/TP.0000000000004666. Epub 2023 Sep 25.
PubMed 37370204Gallon L, Mathew JM, Bontha SV, Dumur CI, Dalal P, Nadimpalli L, Maluf DG, Shetty AA, Ildstad ST, Leventhal JR, Mas VR. Intragraft Molecular Pathways Associated with Tolerance Induction in Renal Transplantation. J Am Soc Nephrol. 2018 Feb;29(2):423-433. doi: 10.1681/ASN.2017030348. Epub 2017 Nov 30.
PubMed 29191961Leventhal JR, Elliott MJ, Yolcu ES, Bozulic LD, Tollerud DJ, Mathew JM, Konieczna I, Ison MG, Galvin J, Mehta J, Badder MD, Abecassis MM, Miller J, Gallon L, Ildstad ST. Immune reconstitution/immunocompetence in recipients of kidney plus hematopoietic stem/facilitating cell transplants. Transplantation. 2015 Feb;99(2):288-98. doi: 10.1097/TP.0000000000000605.
PubMed 25594553
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
- ClinicalTrials.gov ID
- NCT00497926
- Acronym / sponsor ID
- FCR001A2201
- Conditions
- Kidney Failure
- Keywords
- Kidney transplant, Tolerance, Marrow/Enriched Hematopoietic Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: living donor kidney program terminated due to slow pace of phase 3 study enrollment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Talaris Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University, Regenerex, LLC, Duke University
- Study start
- Mar 2008 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
Detailed description
Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living Kidney Allograft | Experimental | Biological: Enriched Hematopoietic Stem Cell InfusionRecipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
- Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation
- Patient is receiving a renal transplant only
- The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis.
- Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion
Key exclusion criteria (8 listed)
- 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 or FCRx infusion
- Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)
- Positive crossmatch between donor and recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched Hematopoietic Stem Cell InfusionEnriched Hematopoietic Stem Cell Infusion | Biological | Living Kidney Allograft |
Primary outcome
Enriched Hematopoietic Stem Cell Engraftment
Time frame: One month to three years
Results and safety
The study was stopped early (reason given: living donor kidney program terminated due to slow pace of phase 3 study enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 37370204Leventhal JR, Galvin J, Ison MG, Feng CY, Ding R, Lee JR, Li C, Mathew JM, Gallon L, Gibson M, Belshe D, Tollerud DJ, Gornstein E, Suthanthiran M, Ildstad ST. Evaluation of Immunocompetence and Biomarkers of Tolerance in Chimeric and Immunosuppression-free Kidney Allograft Recipients. Transplantation. 2023 Oct 1;107(10):e257-e268. doi: 10.1097/TP.0000000000004666. Epub 2023 Sep 25.
- Derived from this study: PubMed 29191961Gallon L, Mathew JM, Bontha SV, Dumur CI, Dalal P, Nadimpalli L, Maluf DG, Shetty AA, Ildstad ST, Leventhal JR, Mas VR. Intragraft Molecular Pathways Associated with Tolerance Induction in Renal Transplantation. J Am Soc Nephrol. 2018 Feb;29(2):423-433. doi: 10.1681/ASN.2017030348. Epub 2017 Nov 30.
- Derived from this study: PubMed 25594553Leventhal JR, Elliott MJ, Yolcu ES, Bozulic LD, Tollerud DJ, Mathew JM, Konieczna I, Ison MG, Galvin J, Mehta J, Badder MD, Abecassis MM, Miller J, Gallon L, Ildstad ST. Immune reconstitution/immunocompetence in recipients of kidney plus hematopoietic stem/facilitating cell transplants. Transplantation. 2015 Feb;99(2):288-98. doi: 10.1097/TP.0000000000000605.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Abrams, MD study director
Talaris Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enriched Hematopoietic Stem Cell Infusion in people with Kidney Failure, run by Talaris Therapeutics Inc. 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: living donor kidney program terminated due to slow pace of phase 3 study enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enriched Hematopoietic Stem Cell Engraftment (time frame: One month to three years). 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 NCT00497926, which also lists 3 linked publications.
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 11 Oct 2023.