Actively Recruiting
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
Led by University of Pittsburgh · Updated on 2025-09-04
2145
Participants Needed
9
Research Sites
182 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with Kidney Disease Improving Global Outcomes (KDIGO) Stage 2 or 3 acute kidney injury with persistent AKI for at least 2 consecutive days based on serum creatinine measurements
You will not qualify if you...
- Acute kidney injury due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
- Diagnosis of end-stage kidney disease at admission, including baseline eGFR below 15 mL/min/1.73m2, previous kidney transplant, or chronic dialysis
- Acute urinary obstruction with rapid kidney function improvement after relief
- Hospitalization involving nephrectomy
- Hospitalization involving solid organ or stem cell/bone marrow transplant
- Dialysis dependence at discharge
- Previous or new referral to a nephrologist within 6 months for specific kidney conditions or electrolyte disorders unrelated to AKI
- Non-kidney end-organ failure including class IV congestive heart failure, decompensated cirrhosis with MELD score over 30 or hepatorenal syndrome, and end-stage pulmonary diseases
- Metastatic or actively treated malignancy
- Life expectancy less than 6 months with palliative care as primary goal
- Pregnancy
- Vulnerable populations such as incarcerated or institutionalized persons
- Inability to provide informed consent due to impaired cognition
- Current enrollment in another higher-risk interventional trial
- Inability to participate in study visits as determined at discharge
- Discharge to long-term acute care or other hospital-based facilities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Cleveland Clinic Weston Hospital
Weston, Florida, United States, 33331
Actively Recruiting
4
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
7
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Nashville VA Medical Center
Nashville, Tennessee, United States, 37212-2637
Actively Recruiting
9
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
S
Susan J Copelli, MSHI
CONTACT
K
Kaleab Abebe, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here