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NCT05027906 (AT-1501 in prevention of rejection in kidney transplantation): BVCT ex-ante prediction vs. reported outcome

On 26 Jan 2025, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 6 Aug 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (iBox) and commercially maybe sufficient (weak efficacy in eGFR).

Clinical Trial

NCTID
NCT05027906
Drug Name
AT-1501 (Tegoprubart)
Drug MoA
anti-CD40L inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
prevention of rejection in kidney transplantation
Human Patients
48
Sponsor
Eledon Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 625

Prospective Prediction
Prediction Index
625
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet weak additive clinical benefit in eGFR/graft survival/BPAR at most numerically superior to tacrolimus)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in eGFR compared with placebo featuring negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
192 days in advance
Readout Data Interpretation
tegoprubart stabilized eGFR at 63 mL/min/1.73 m2 and achieved -4.11 iBox score at 12 months; both are numerically superior to calcineurin inhibitors (e.g. tacrolimus) that stabilised eGFR at 53 mL/min/1.73 m2 and achieved -2.98 iBox score at 12 months
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (iBox) and commercially maybe sufficient (weak efficacy in eGFR)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
48
Lead sponsor
Eledon Pharmaceuticals
Conditions
Prevention of Rejection in Kidney Transplant
Interventions
DRUG: AT-1501
Design
Single group · None
Primary purpose
Treatment
Start
2022-02-18
Primary completion
2027-01
Completion
2027-01
Primary outcomes
  • Safety Incidences (Through study completion, an average up to 20 months)
  • Pharmacokinetic- PK profile (Day 1 and at steady state Month 3)
  • Pharmacokinetic- Area under the plasma concentration (Day 1 and at steady state Month 3)
  • Pharmacokinetic- Cmax (Day 1 and at steady state Month 3)
  • Pharmacokinetic- Tmax (Day 1 and at steady state Month 3)

NCT05027906 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials