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NCT05805709: COPE-AKI

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

Recruiting now NA Last updated 4 September 2025
What this trial tests

NA trial testing Study Physician/Advance Practice Provider in Acute Kidney Injury in 2,145 participants. Currently enrolling.

Timeline
5 September 2023
Primary endpoint
5 June 2026
5 March 2027

Quick facts

Lead sponsorUniversity of Pittsburgh
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment2,145
Start date5 September 2023
Primary completion5 June 2026
Estimated completion5 March 2027
Sites9 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Unveiling the enigma of acute kidney disease: predicting prognosis, exploring interventions, and embracing a multidisciplinary approach.
    Pan SY, Huang TT, Jiang ZH, Lin LC, et al · · 2024 · cited 5× · PMID 38934037 · DOI 10.23876/j.krcp.23.289
  2. Improving Processes of Care after Acute Kidney Injury.
    Gregg LP, Leaf DE, Leaf DE. · · 2025 · PMID 39446577 · DOI 10.1681/asn.0000000548

Verify or expand the search:

Other recruiting trials for Acute Kidney Injury

Currently open trials in the same condition.

Other University of Pittsburgh trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05805709.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing