NCT07091214

Molecular Transcriptomics in Diagnosing Pediatric Kidney Transplant Rejection: the PANDA-Kids-ATLAS Study

Precision Allograft Rejection Using Novel Diagnostic Approaches in Kidney Transplantation - Allograft Transcriptomics Landscape Analysis Using Sequencing (the PANDA-Kids-ATLAS Study)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Paris Translational Research Center for Organ Transplantation · Academic / Other
• Sex: All
• Age: 0 Years – 21 Years
• Healthy volunteers: Accepted

Summary

Children with kidney failure have markedly increased mortality and face repeated transplantation over their lifetime due to limited allograft half-life (12-15 years). Current biopsy-based diagnoses of rejection (using Banff 2022 criteria) suffer from variability and limited sensitivity. PANDA-Kids-ATLAS will analyze up to 600 pediatric FFPE kidney biopsies across multiple centres using the Banff Human Organ Transplant (B-HOT) NanoString panel to develop and validate molecular classifiers of AMR, TCMR and related phenotypes. A secure REDCap database will integrate molecular, pathological and clinical data, aiming to improve early detection, personalize therapy, and enhance long-term graft survival and patient quality of life.

Detailed description

The study builds a deeply phenotyped international cohort of pediatric transplant patients (\<21 years) with both retrospective (2014-present) and prospective (through Dec 2027) biopsy sampling. Four diagnostic "baskets" (classical AMR/TCMR; probable ABMR/MVI; other injury; normal) will each contribute equal numbers of cases for classifier validation (Part A) and real-world prevalence samples for outcome association (Part B). FFPE blocks will be centrally reviewed via Banff 2022 automated and expert pathologist interpretation, then processed by NanoString nCounter® using the 770-gene B-HOT panel. Stratified random sampling, robust QC, and integration with clinical/immunological parameters in REDCap will underpin molecular classifier development and validation. Follow-up includes clinical outcomes and graft function monitoring.

Conditions

• Kidney Rejection Transplant

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: France