A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial (NCT05805709)
Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
- Study Physician/Advance Practice Provider (OTHER)
- Nurse Navigator (OTHER)
- Pharmacist (OTHER)
- Patient Education (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Yale University — New Haven, Connecticut
- Cleveland Clinic Weston Hospital — Weston, Florida
- University of Maryland — Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland
- MetroHealth — Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
- Nashville VA Medical Center — Nashville, Tennessee
- Vanderbilt University — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (412) 245-0803
Email: sju1@pitt.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Kidney Injury
- An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury — Chicago, Illinois
- Acute Kidney Injury Genomics and Biomarkers in TAVR Study — Dallas, Texas
- Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury — Boston, Massachusetts
- Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage — Oklahoma City, Oklahoma
- Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy — Montreal, Quebec
- A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" — Birmingham, Alabama
Explore by condition: All Acute Kidney Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.