A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501677-39-00

Acronym

IM103402

Enrollment

Registered

2023-02-08

Start date

2021-05-25

Completion date

Unknown

Last updated

2025-08-21

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

Conditions

Adolescent Renal Allografts

Brief summary

Proportion of participants who survive with a functional graft with an eGFR > 30 mL/min/1.73 m2 (updated Schwartz formula), 24 months post-randomization.

Interventions

DRUGCICLOSPORIN

DRUGTACROLIMUS

DRUGbelatacept

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Proportion of participants who survive with a functional graft with an eGFR > 30 mL/min/1.73 m2 (updated Schwartz formula), 24 months post-randomization.	—

Countries

Belgium, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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