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BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503337-21-00
Acronym
AT-1501-K209
Enrollment
30
Registered
2025-01-08
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of Renal Allograft Rejection

Brief summary

Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs)., Changes in vital signs and clinical laboratory measures., Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.

Detailed description

Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis, The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2, The mean eGFR at 12, 24, 36, and 48 months, Proportion of participants with BPAR at 12, 24, 36, and 48 months, Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months

Interventions

Sponsors

Eledon Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs)., Changes in vital signs and clinical laboratory measures., Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.

Secondary

MeasureTime frame
Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis, The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2, The mean eGFR at 12, 24, 36, and 48 months, Proportion of participants with BPAR at 12, 24, 36, and 48 months, Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026