Kidney Transplant RejectionPhase 3NCT03363945
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
A Phase 3 study testing MDR-101 in people with Kidney Transplant Rejection, run by Medeor Therapeutics, Inc. at 19 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- MDR-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 15 Mar 2018to 11 Apr 2024
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Recipient Inclusion Criteria:
- Planned recipient of a first kidney allograft from an HLA-matched, living related donor
- Age ≥18 and ≤70 years
- Single solid organ recipient (kidney only)
- ABO matched 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 or half sibling) relative of the prospective recipient participant
- Age ≥18 and ≤70 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, T. cruzi, or syphilis
- History of infection with Zika virus
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
University of Colorado Denver
Aurora, Colorado, 80045
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Baylor University Medical Center
Dallas, Texas, 75246
INOVA Fairfax Hospital
Fairfax, Virginia, 22031
The Methodist Hospital
Houston, Texas, 77030
Mayo Clinic Hospital
Jacksonville, Florida, 32224
Loma Linda University Medical Center
Loma Linda, California, 92354
USC
Los Angeles, California, 90033
University of Wisconsin School of Medicine
Madison, Wisconsin, 53792
Loyola University Medical Center
Maywood, Illinois, 60153-3328
Intermountain Transplant Center
Murray, Utah, 84107
Yale University
New Haven, Connecticut, 06519
RWJBarnabas Health
Orange, New Jersey, 07052
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University Medical Center
Stanford, California, 94305
Upstate University Hospital
Syracuse, New York, 13210
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Canada1 site
CIUSSS de l'Est- de-l'Île-de-Montréal Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
About this study
Official title: A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants
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.
Read the detailed description
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients' immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs.
The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.
- Conditions
- Kidney Transplant Rejection
- Being tested
- MDR-101
- Keywords
- kidney transplant, cellular therapy, anti-rejection therapy, living donor, HLA-matched, hematopoietic stem cells (HSC), CD34+, CD3+, T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR-101Biological
Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
| Study group | Role | What they receive |
|---|---|---|
| MDR-101 | Active comparator | A single dose will be administered via IV infusion post-kidney transplant. Receives: Biological: MDR-101 |
| Control Arm | No intervention | Subjects randomized to this arm will receive the standard anti-rejection medications that would be given to kidney transplant recipients who are outside the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional immune tolerance defined as
- Achievement of the required duration of persistent donor mixed chimerism to permit calcineurin inhibitor immunosuppressive withdrawal beginning at 6-7 months post-kidney transplant surgery, and
- Successful withdrawal from all immunosuppressives by at least 12 months post-kidney transplant surgery, and
- Subsequent successful maintenance off all immunosuppressive drugs for at least 24 additional months (out to at least 36 months post-kidney transplant surgery) without biopsy-proven acute rejection, de novo Donor Specific Antibody, transplant kidney loss, or subject death. Loss to follow-up will be adjudicated as a failure in intent-to-treat analysis.
Measured: Up to 36 months post-kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start15 Mar 2018
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total lymphoid irradiation and anti-thymocyte globulin
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medeor Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Lenuta Micsa, MD, Study director, Medeor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363945
- Sponsor's protocol ID
- MDR-101-MLK
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2017
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants
- ClinicalTrials.gov ID
- NCT03363945
- Acronym / sponsor ID
- MDR-101-MLK
- Conditions
- Kidney Transplant Rejection
- Keywords
- kidney transplant, cellular therapy, anti-rejection therapy, living donor, HLA-matched, hematopoietic stem cells (HSC), CD34+, CD3+
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medeor Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 6 Dec 2017 (actual)
- 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.
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.
Detailed description
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients' immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs.
The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total lymphoid irradiation and anti-thymocyte globulin
| Arm | Type | Receives |
|---|---|---|
| MDR-101 | Active comparator | Biological: MDR-101A single dose will be administered via IV infusion post-kidney transplant. |
| Control Arm | No intervention | –Subjects randomized to this arm will receive the standard anti-rejection medications that would be given to kidney transplant recipients who are outside the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MDR-101Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells | Biological | MDR-101 |
Primary outcome
Functional immune tolerance defined as
Time frame: Up to 36 months post-kidney transplant
* Achievement of the required duration of persistent donor mixed chimerism to permit calcineurin inhibitor immunosuppressive withdrawal beginning at 6-7 months post-kidney transplant surgery, and * Successful withdrawal from all immunosuppressives by at least 12 months post-kidney transplant surgery, and * Subsequent successful maintenance off all immunosuppressive drugs for at least 24 additional months (out to at least 36 months post-kidney transplant surgery) without biopsy-proven acute rejection, de novo Donor Specific Antibody, transplant kidney loss, or subject death. Loss to follow-up will be adjudicated as a failure in intent-to-treat analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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.
Lenuta Micsa, MD study director
Medeor Therapeutics
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MDR-101 in people with Kidney Transplant Rejection, run by Medeor Therapeutics, Inc. at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional immune tolerance defined as (time frame: Up to 36 months post-kidney transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.