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Real World Evidence Clinical Utility Study of KidneyIntelX

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2, 2024 → Dec 1, 2026
See other at-risk trials from Renalytix AI, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2, 2024 to Dec 1, 2026v7
  2. Primary completion date: Dec 2, 2023 to Dec 2, 2024v6
  3. Enrollment target: 6000 to 10000
    • Primary completion date: Mar 2, 2023 to Dec 2, 2023
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Primary endpoints: 5 to 4
    • Eligibility criteria expanded, about 6 words
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.
Trial Details
NCT Number NCT04802395
Lead Sponsor Renalytix AI, Inc.
Collaborators: Mount Sinai Hospital, New York
Conditions
(from sponsor)		 Chronic Kidney Diseases, Diabetic Kidney Disease
Related terms Diabetic Nephropathies, Renal Insufficiency, Chronic
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov