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A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI)- (299AR201-TRANSPIRE)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521742-15-00
Enrollment
13
Registered
2026-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-10

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

Conditions

Treatment of Late Isolated Microvascular Inflammation in Recipients of Kidney Transplants

Brief summary

Percentage of participants who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria)

Detailed description

Part A : • MVI score at Week 24 (Month 6) (Banff 2022 criteria) • Percentage of participants who achieve MVI score of 0 at Week 24 (Banff 2022 criteria) • Change in eGFR from Baseline to Week 24 • Percentage of participants in the C4d-positive cohort who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria), Part B Arm 1:• Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve the MVI score of 0 (Banff 2022 criteria) • Change in estimated glomerular filtration rate (eGFR) from Baseline • Time to all-cause allograft loss, Part B Arm 2: • Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve MVI score of 0 (Banff 2022 criteria) • Change in eGFR from Week 24 • Time to all-cause allograft loss, Parts A and B: • Incidence and severity of adverse events (AEs) [treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)] • Percentage of participants with TCMR on biopsy at Week 24 and at Week 52 (Banff 2022 criteria) • Laboratory assessments, vital sign measurements, and ECG

Interventions

Sponsors

Biogen Idec Research Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria)

Secondary

MeasureTime frame
Part A : • MVI score at Week 24 (Month 6) (Banff 2022 criteria) • Percentage of participants who achieve MVI score of 0 at Week 24 (Banff 2022 criteria) • Change in eGFR from Baseline to Week 24 • Percentage of participants in the C4d-positive cohort who achieve BPHR at Week 24 (Month 6) (Banff 2022 criteria), Part B Arm 1:• Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve the MVI score of 0 (Banff 2022 criteria) • Change in estimated glomerular filtration rate (eGFR) from Baseline • Time to all-cause allograft loss, Part B Arm 2: • Percentage of participants who achieve BPHR (Banff 2022 criteria) • MVI score (Banff 2022 criteria) • Percentage of participants who achieve MVI score of 0 (Banff 2022 criteria) • Change in eGFR from Week 24 • Time to all-cause allograft loss, Parts A and B: • Incidence and severity of adverse events (AEs) [treatment-emergent adverse events (TEAEs), serious adverse e

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 11, 2026