A public-private partnership

TRACK Consortium

Therapeutic and Regulatory Science
Advancement in Congenital Kidney Disease

A public-private partnership advancing the therapeutic and regulatory science infrastructure needed to support development and trials in congenital kidney disease, particularly CAKUT. Its multi-stakeholder participants include academic centers, regulators such as the FDA, government partners, and patient and caregiver organizations.

TRACK Consortium participants at the Road to Trial Readiness Summit
Summit panel session
Summit participants voting on the framework
Road to Trial Readiness Summit · FDA, Silver Spring MD · April 2026
Multi-stakeholderAcademic, regulatory, industry, and patient partners
Inaugural summitApril 2026, Silver Spring MD
StructurePre-competitive, voluntary, open
Purpose

Building the resources to enable therapeutic development and trials in congenital kidney disease

Congenital anomalies of the kidney and urinary tract (CAKUT) and related conditions are a leading cause of chronic kidney disease in children and young adults. Decades of natural history data, deep clinical expertise, and established cohorts have accumulated, yet no dedicated therapeutic program has been developed for this patient population.

TRACK is a pre-competitive consortium organized to address the gaps in trial inclusion, endpoint development, and trial feasibility, producing shared scientific work as public goods available to all.

Coordinating organization
KidneyFuture (formerly the CAKUT Foundation), a patient and caregiver-led foundation focused on congenital kidney disease outcomes and research
Regulatory participation
A public-private partnership whose participants include regulators such as the FDA.
Participation model
Voluntary and project-based, with no membership fees or institutional commitments.
Current status

Progress to date

The inaugural Road to Trial Readiness Summit concluded in April 2026 with regulator engagement and community-level direction on the path forward. Active workstreams are now underway.

Consortium
formation
Summit
convened
Manuscript
submission
Inclusion criteria
calibration
CAKUT
toolkit
Endpoint & biomarker
development
Fall 2026
workshop

Updated quarterly — next update October 2026

Scientific framework

The consortium's work is organized around four interconnected deliverable areas.

01

Patient segmentation and high-risk mapping

02

Endpoints and prognostic enrichment

03

Regulatory-grade data package

04

Trial design specifications

Consortium participants

A multi-stakeholder scientific effort

TRACK includes participants across every constituency required to advance therapeutic development in this field.

Pediatric and adult nephrology

Clinical and translational expertise from academic medical centers across North America and Europe, including leading CAKUT specialists.

Research cohorts and registries

Major international cohorts and registries contributing data across multiple countries for threshold analyses and biomarker validation.

Industry partners

Pharmaceutical and biotechnology companies participating in pre-competitive scientific dialogue on trial design, endpoints, and regulatory strategy.

Regulatory agencies

Regulators are engaged as participants in the consortium, including the U.S. Food and Drug Administration. The consortium's scientific outputs are designed to be relevant to regulatory decision-making.

Patient and caregiver organizations

Patient and caregiver perspectives shape endpoint definitions, acceptability criteria, and the consortium's research priorities throughout.

Urology and related specialties

Pediatric urology and other specialties relevant to CAKUT and the urinary tract, contributing surgical and anatomical expertise to trial design and patient selection.

Participation

An open, pre-competitive consortium

TRACK operates as an explicitly pre-competitive consortium. All frameworks, threshold analyses, and endpoint hierarchies produced are shared with the field as public goods, available without restriction to academic and industry sponsors.

Institutions, cohorts, and organizations with a stake in advancing therapeutic trials for congenital kidney disease are encouraged to participate. Working groups are evolving as the consortium develops.

Contact the coordinating team

General inquiries and participation
info@trackconsortium.org
Coordinating organization
KidneyFuture Foundation (formerly the CAKUT Foundation)
trackconsortium.org
Slides and toolkit materials
Access meeting slides →
Progress report
View current progress report →
About

About the TRACK Consortium

Organizational background, governance structure, and scientific rationale.

Origin and rationale

CAKUT and related congenital kidney conditions are a leading cause of chronic kidney disease in children and young adults, where early progression carries lifelong consequences. The community has built real assets around them: decades of natural history and cohort data, deep clinical expertise, and engaged patients, researchers, and sponsors.

What has been missing is a shared structure that brings these assets together. TRACK is that unifying effort, connecting work that has largely advanced in separate silos so the field can move toward therapeutic trials as one coordinated community.

Scientific framework

The April 2026 Road to Trial Readiness Summit set the initial direction across the consortium's four working areas: patient segmentation and high-risk mapping, endpoints and prognostic enrichment, a regulatory-grade data package, and trial design specifications.

The work is pre-competitive, and its outputs are shared openly as public goods, available to any academic or industry sponsor developing therapies for this population.

Governance and coordination

The consortium is coordinated by KidneyFuture (formerly the CAKUT Foundation), a patient- and caregiver-led nonprofit focused on congenital kidney disease. Scientific activities are guided by a planning group of clinical experts and patient representatives, and participation is voluntary. Governance continues to evolve as the consortium grows.

Regulatory and public-sector engagement

Regulators, including the U.S. Food and Drug Administration, are engaged as participants in the consortium, and the April 2026 summit was held at the FDA's Silver Spring campus. The consortium's outputs are designed to be relevant to regulatory decision-making and usable by any sponsor.

Follow the work in progress

The public progress report tracks active workstreams, the publications pipeline, and participating cohorts, updated quarterly.

Coordinating organization

KidneyFuture (formerly the CAKUT Foundation)
kidneyfuture.org

Contact

info@trackconsortium.org

Participation

No membership fees or institutional commitments. Participation is voluntary and project-based. Contact the coordinating team to discuss involvement.

Progress report

Quarterly updates on all active workstreams. View current report →

Public Progress Report — July 2026

TRACK Consortium progress report

Status of active workstreams, the publications pipeline, and participating data partners. Updated quarterly.

April 16–17, 2026Summit completed, Silver Spring MD
Multi-stakeholderClinicians, FDA, industry, patients
Active workstreamsCriteria, endpoints, manuscript
Next updateJuly 2026

The summit has concluded. TRACK is now an active consortium. Workstreams are underway. This page is updated quarterly.

Where We Are

Project milestones

Consortium
formation
Summit
convened
Manuscript
submission
Inclusion criteria
calibration
CAKUT
toolkit
Endpoint & biomarker
development
Fall 2026
workshop
Active Work

Workstream status

Consortium formation
Complete

The TRACK Consortium has been formally established as a multi-stakeholder collaborative including clinicians, researchers, industry partners, patient advocates, and regulatory agencies.

A voluntary, pre-competitive collaborative open to new participants.
Road to Trial Readiness Summit
Complete

A two-day summit convened April 16–17, 2026 at the FDA Great Room in Silver Spring, Maryland. It produced the first community-level framework on trial inclusion criteria, prognostic markers, patient perspectives, and enrichment and stratification approaches for a CAKUT trial.

Proceedings manuscript in preparation — see Publications below
Manuscript submission
In Progress

The summit proceedings manuscript is drafted and currently under author review. The goal is submission for peer review within 90 days.

Currently in author review across the consortium's contributors.
Inclusion criteria calibration
In Progress

A directional framework on criteria structure was established at the summit. A federated cohort analysis is being initiated to establish numeric thresholds, with efforts underway to incorporate additional global datasets.

Collaborative analysis across registries and academic centers in the United States and Europe.
CAKUT toolkit
In Progress

An in-depth toolkit for academic and industry use in therapeutic development. It brings together the topics addressed at the summit, from patient science to trial endpoints, prognostic enrichment, and the path to a viable program, into an openly shared, practical resource.

Developed as a practical companion to the summit proceedings.
Endpoint and biomarker development
Initiated

Work is underway to characterize prognostic enrichment markers and identify surrogate endpoint candidates, in parallel with the inclusion criteria pooled analysis.

Findings will be informed by the pooled cohort analyses
Manuscripts

Publications pipeline

Summit Proceedings: Strategies for therapeutic development in pediatric and young-adult CAKUT
Meeting report  •  Currently in author review  •  Goal: submission within 90 days
In Review
Drafted
Author review
Full circulation
Submitted
Published
  • ✓Multi-stakeholder authorship assembled across clinical, scientific, and regulatory contributors
  • ✓Directional framework documented and incorporated throughout
  • ✓Inclusion criteria directional decisions captured
  • ✓Prognostic, enrichment, and feasibility biomarker signals captured
  • □Supporting figures in preparation
  • □Final author review and approval pending
Infrastructure

Participating cohorts and data partners

Multiple established cohorts and registries across North America and Europe are collaborating to support the consortium's threshold and biomarker analyses, representing patients from many countries.

Cohort / RegistryGeography
esCapeKDEurope
ERKReg / ERKNet26 European countries
4C StudyEurope
ESCAPE TrialEurope
CKiDNorth America
PEDSnetUnited States
ARTDECONetherlands
KIMONONetherlands
RADARUK / International
PRESERVEUnited States
Looking Ahead

Supplemental and planned workstreams

These are additional and future workstreams beyond the active priorities above, at varying stages of planning.

01

Fall 2026 follow-up workshop

A second convening is being planned for fall 2026, bringing together industry representatives, biostatisticians, and platform trial architects to translate threshold calibration findings into actionable trial design specifications.

Being Planned
02

Patient and Young Adult Leadership Councils

KidneyFuture is initiating a Parent-Patient Council and a Young Adult Leadership Council as standing advisory bodies to the consortium, ensuring patient and caregiver perspectives inform endpoint definitions and acceptability criteria.

Initiated
03

Common data elements harmonization

Aligning data definitions, biomarker platforms, and analytic approaches across participating cohorts to support robust pooled analyses, modeled on the PARASOL initiative in glomerular disease.

Pending
04

CAKUT biomarker panel in adult CKD trials

Engaging adult CKD trial sponsors to incorporate the CAKUT biomarker panel for cross-lifespan characterization. Identified as a priority at the April 2026 summit.

Pending
05

Transition-age cohort (ages 18–22) in existing adult CKD trials

A near-term strategy to generate clinical data on young adult CAKUT patients within existing adult trial infrastructure, where regulatory pathways are more established.

Pending
06

Under-2 cohort safety framework

A safety-data-generating approach for children under 2 years of age, using nadir creatinine rather than eGFR, without requiring a separate efficacy endpoint in this age group.

Pending
Slides & Toolkit

Meeting slides & toolkit resources

Presentation materials and toolkit resources from TRACK meetings and the Road to Trial Readiness Summit. Available to consortium participants and others on request.

🔒

Request access

Slide decks and toolkit materials are available to consortium participants and to others on request. Enter the access password below to view and download, or contact us to request one.

Don't have a password? Email info@trackconsortium.org to request access.

April 2026

Road to Trial Readiness Summit — Silver Spring, MD

📊
Summit — Day 1 presentations
April 16, 2026  •  Silver Spring, MD
↓ Download .pptx
📊
Summit — Day 2 presentations
April 17, 2026  •  Silver Spring, MD
↓ Download .pptx
📚
CAKUT trial-readiness toolkit
In development  •  Academic & industry use
Request early access →

Additional materials will be posted here as meetings occur. Contact info@trackconsortium.org with questions.