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

Paris Translational Research Center for Organ Transplantation

Status: Not yet enrolling

Conditions: Kidney Rejection Transplant

Study type: Observational

Funder types: Other

Identifiers

NCT07091214

Transcriptomics_PED_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≤ 21 years
• Single kidney transplant recipients (deceased or living donor)
• Written informed consent from patients/guardians

Exclusion criteria

• Multi-organ transplantation history
• Biopsies with insufficient tissue

Trial design

600 participants in 4 patient groups

Group 1: Classic rejection profile

Description:

Active/chronic AMR or TCMR

Group 2: Other rejection profiles

Description:

Probable AMR, MVI+DSA- C4d-, borderline or mixed rejection

Group 3: Other diagnoses

Description:

CMV, CNI toxicity, recurrence, BK nephropathy

Group 4: Normal biopsies

Description:

No lesions (normal biopsy results)