Tegoprubart for the Prevention of Rejection in Kidney Transplant: Update of Emerging Data from an Ongoing Trial
Bibliographic record
Abstract
Background: Tegoprubart is a monoclonal antibody directed against the CD40 ligand (CD40L), a key mediator of co-stimulation. Inhibition of CD40L should result in a decrease in both cell and antibody mediated immunity and create a more tolerogenic immune environment. Tegoprubart has been shown to be effective in animal models and is currently being studied in kidney transplant recipients. It is being assessed to determine whether it can provide similar prevention of rejection as tacrolimus with superior graft function. Methods: 12 adults receiving a kidney transplant from either a living or deceased donor will be enrolled. To be eligible, this must be their first transplant, they must be seropositive for EBV, free of donor specific antibodies, have low panel reactive antibodies, and the organ cannot be from an extended criteria donor or have a prolonged cold ischemia time. All participants will receive rATG and a regimen consisting of tegoprubart 20 mg/kg IV administered every 3 weeks after initial loading, mycophenolate and corticosteroids. The primary endpoint is safety at one year. Secondary endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection (BPAR) and changes in estimated glomerular filtration rate (eGFR). Results: As of the abstract submission deadline, May 2023, 5 participants have been transplanted, and 3 are ongoing. No participant has experienced rejection. One discontinued due to an SAE of BK viremia and another for mild alopecia and fatigue. BK viremia was the only SAE reported to date, and the drug appears safe and well tolerated. Participant information is summarized in Table 1, and mean eGFR is summarized in Figure 1.Figure 1.: Mean eGFR in ML/min/1.73m 2Conclusions: Improved graft function may improve long term outcomes in kidney transplantation. It is postulated that tegoprubart could be an alternative therapy for prevention of rejection in kidney transplant recipients. Data to date are encouraging, with no rejections, a good safety profile and excellent allograft function. Funding: Commercial Support - Eledon Pharmaceuticals Inc
Stored with the screening record, where it is evidence for the labels above.
How this classification was reachedexpand
The three-model screen
all 5,600 screened works →All three models called this out of scope.
Interim clinical trial results for an antibody preventing kidney transplant rejection.
The work reports a kidney-transplant treatment trial rather than studying research methods.
Clinical transplant trial update on an immunosuppressive drug, domain medicine.
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 | 0.007 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".