Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
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| ClinicalTrials.gov Identifier: NCT03363945 |
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Recruitment Status :
Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : August 24, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Transplant Rejection | Biological: MDR-101 | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Total lymphoid irradiation and anti-thymocyte globulin |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | March 15, 2018 |
| Estimated Primary Completion Date : | April 2024 |
| Estimated Study Completion Date : | April 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: MDR-101
A single dose will be administered via IV infusion post-kidney transplant.
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Biological: MDR-101
Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells |
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No Intervention: Control Arm
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.
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- 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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363945
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| Study Director: | Lenuta Micsa, MD | Medeor Therapeutics |
| Responsible Party: | Medeor Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03363945 |
| Other Study ID Numbers: |
MDR-101-MLK |
| First Posted: | December 6, 2017 Key Record Dates |
| Last Update Posted: | August 24, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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kidney transplant cellular therapy anti-rejection therapy living donor HLA-matched |
hematopoietic stem cells (HSC) CD34+ CD3+ T cells |