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A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial

Study acronym: COPE-AKI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Nurse Navigator (Other), Patient Education (Other), Pharmacist (Other), Study Physician/Advance Practice Provider (Other) to Nurse Navigator (Other), Patient Education (Other), Pharmacist (Other), Study Physician/Advance Practice Provider (Other) Eligibility criteria expanded, about 29 words · Secondary endpoints revised (6) Show 2 more changesShow less
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (6)
  2. Primary completion date: Jun 5, 2026 to Feb 28, 2028 Completion date: Mar 5, 2027 to Nov 30, 2028v8 Show 1 more changeShow less
    • Completion date: Mar 5, 2027 to Nov 30, 2028
  3. Site contacts updated at 9 of 9 sitesv7
  4. Study sites: 7 to 9v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 1, 2026 to Jun 5, 2026 · Completion date: Feb 1, 2027 to Mar 5, 2027 · Start date changed from estimate of Aug 1, 2023 to Sep 5, 2023 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: May 1, 2026 to Jun 5, 2026
    • Completion date: Feb 1, 2027 to Mar 5, 2027
    • Start date changed from estimate of Aug 1, 2023 to Sep 5, 2023
    • Site details revised at 7 of 7 sites
  2. Start date: May 1, 2023 to Aug 1, 2023 Primary completion date: Feb 1, 2026 to May 1, 2026 · Completion date: Nov 1, 2026 to Feb 1, 2027v3 Show 2 more changesShow less
    • Primary completion date: Feb 1, 2026 to May 1, 2026
    • Completion date: Nov 1, 2026 to Feb 1, 2027
  3. Primary completion date: Aug 30, 2025 to Feb 1, 2026 Completion date: Aug 30, 2026 to Nov 1, 2026v2 Show 1 more changeShow less
    • Completion date: Aug 30, 2026 to Nov 1, 2026
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.
Trial Details
NCT Number NCT05805709
Lead Sponsor University of Pittsburgh
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Acute Kidney Injury
Enrollment 2,145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov