Why this page exists: Scaling your Kidney Protection Project from a pilot to an EU-wide study requires funding. This page presents the Executive Summary and 7-Block Blueprint of a €2.4M Horizon Europe Grant application, positioning the Vera infrastructure for future EHDS secondary health data mandates.
How to use this for your Kidney Trial:
Present the **Strategic EHDS Positioning Note** highlighting how the platform leverages ZKPs and EUDI wallets to achieve native compliance ahead of the March 2029 EU mandate.
Walk through the **Consortium Partners** section mapping the collaborative roles of Lebensfluss e.V. (Technology), your US clinic (Clinical PI), and EUDI Wallet Partners (Consent).
Review the **Roadmap phases** detailing the transition from the Pilot (Phase 0) to Grant (Phase 1) and full scale-out (Phase 2).
Explain the **Consolidated Budget table** showing where and how the requested €2.4M is allocated.
💡 Use this summary to pitch potential co-sponsors, consortium partners, or academic co-investigators.➡️ Next Step: Academic PhD Whitepaper →
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Horizon Europe · HORIZON-HLTH-2025-IND-13-01
Vera Clinical — Holistic Nephrology Biomarker Platform
A multi-modal, ZKP-secured, GDPR-compliant research platform correlating integrative medicine biomarkers with eGFR trajectory in CKD. EU Grant Executive Summary — 7-Block Blueprint.
The European Health Data Space (EHDS) secondary use rules (Regulation (EU) 2025/327) enter into force progressively from March 2027 and full secondary use provisions apply from March 2029. This grant application positions the Vera Clinical infrastructure as EHDS-readiness investment: the ZKP pseudonymisation architecture, EUDI consent framework, and federated data model are designed to be natively compliant with EHDS secondary use requirements once they apply. Grant funds infrastructure capability built ahead of regulatory mandate.
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THE PROBLEM
Chronic Kidney Disease (CKD) affects 850 million people globally and costs EU healthcare systems €140 billion annually. Once patients reach Stage 5 (eGFR <15), conventional nephrology offers only dialysis or transplant. Five-year mortality on dialysis exceeds 60%. No approved treatment restores kidney function.
Meanwhile, integrative medicine practitioners report anecdotal CKD improvement through holistic protocols, but lack the scientific infrastructure to document, validate, or publish these observations. Biometric data is collected ad hoc, without tamper-evidence, without standardised measurement, and without GDPR-compliant data sovereignty.
The result: a catastrophic research gap. Potentially impactful integrative protocols remain invisible to mainstream nephrology because the evidence infrastructure does not exist.
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THE TECHNOLOGY
🔬 5-Vector Vera Measurement Platform
VeraTongue — TCM topography, Water Element score (image analysis)
Synthetic differentially-private export for open science
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THE SOLUTION
The Vera Clinical platform provides the world's first GDPR-compliant, ZKP-secured, multi-modal holistic biomarker research infrastructure for integrative nephrology. It enables practitioners to systematically capture, commit, and correlate holistic wellness measurements with validated clinical biomarkers (eGFR, creatinine) across a longitudinal study cohort.
The pilot case study (n=1, published as whitepaper pre-print) demonstrated eGFR improvement from 12.4 to 41.8 mL/min/1.73m² (237%) with dialysis discontinuation at T-End. All five Vera vectors showed Pearson r >0.99 co-movement with eGFR trajectory. This grant funds the multi-site expansion to n=30+ to generate statistically powered, peer-reviewable evidence.
This is not a treatment trial. It is a biomarker correlation study that documents whether holistic measurement vectors can serve as surrogate markers for kidney function recovery — regardless of the intervention used. This research-neutral framing makes it fundable across conventional and integrative medicine programme lines.
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MARKET OPPORTUNITY
📊 Market Size
850M CKD patients globally (GBD 2020)
€140B/year EU CKD direct cost
2.5M dialysis patients worldwide
€32B/year global dialysis market (growing 5% CAGR)
Any meaningful % reduction in dialysis dependency = €Bn impact
🎯 Target Users
Integrative medicine practitioners treating CKD patients
Academic nephrology departments (multi-site study partners)
EU Health Data Space (EHDS) national data hubs
Insurance providers exploring integrative care cost-reduction
EU patient advocacy groups (CKD patient organizations)
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CONSORTIUM
Technology Lead · WP1 + WP3
Lebensfluss e.V. / OHM Institute
Austria · Vera Clinical platform development, ZKP infrastructure, GDPR compliance architecture, AI Act compliance, EHDS integration. Budget: €900K.
Principal Investigator · WP2
Dr. Johannes K., M.D.
USA · Clinical PI, integrative medicine protocol design, patient recruitment, Ethics Committee liaison, publication authorship. Budget: €400K (subgrant).
Identity & Consent Layer · WP4
EUDI Wallet Partner
EU · EUDI wallet integration for cryptographic patient consent. Regulation (EU) 2024/1183 deployment. Cross-border identity verification. Budget: €300K.
🗓️ Work Package Structure
WP1 — Platform Hardening (M1-6): EU AI Act conformity assessment, MDR scope documentation, cybersecurity audit, GDPR Art.35 DPIA final approval
WP2 — Multi-Site Study (M6-30): Ethics Committee approval, n=30 patient enrolment across 3 sites, longitudinal data collection, statistical analysis
WP3 — Data Infrastructure (M1-36): ZKP Merkle tree scaling, EHDS-compatible API, synthetic export pipeline, open science data publication
Claim Area 2: Federated ZKP aggregation with differential privacy synthetic export (privacy-preserving open science)
Claim Area 3: Deterministic XAI explanation report method for EU AI Act Art.13 compliance in wellness measurement systems
All IP developed under this grant will be owned by the consortium per the Horizon Europe IP framework (Article 36 Grant Agreement). Background IP (Vera platform) remains with Lebensfluss e.V.