Induction of immune tolerance in living related human leukocyte antigen–matched kidney transplantation: A phase 3 randomized clinical trial
Bibliographic record
Abstract
This phase 3 multicenter, randomized, controlled clinical trial evaluated investigational cellular product (MDR-101) to produce immune tolerance vs standard of care, in kidney transplant recipients. Adult recipients of kidneys from 2-haplotype human leukocyte antigen-matched living siblings were randomized 2:1 to treatment (n = 20) or control (n = 10). The MDR-101 product was from the same kidney donor. Treatment recipients received a nonmyeloablative conditioning protocol with rabbit-antithymocyte globulin and low-dose total lymphoid irradiation (10 fractions). MDR-101 was infused (day 11). Steroids were withdrawn by day 10 and mycophenolate by day 39. Tacrolimus was continued until day 180 and tapered to withdrawal 1-year posttransplant if donor hematopoietic mixed chimerism was ≥5%. Controls received immunosuppression (IS) per institutional standard of care. Twenty recipients received the MDR-101 infusion, and none developed graft versus host disease. Nineteen (95%) successfully discontinued all IS approximately 1 year after kidney transplant. Fifteen (75%) reached the primary study endpoint of IS-free for >2 years. Four resumed IS: 1 with recurrent immunoglobulin A nephropathy; 1 with recurrent immunoglobulin A nephropathy and rejection; 1 with rejection; and 1 with borderline biopsy changes. Kidney transplant recipients receiving MDR-101 achieved donor mixed chimerism and functional immune tolerance for greater than 2 years with no death, graft loss, DSA, or graft versus host disease and demonstrated improved quality of life compared to standard treatment.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".