A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial
- Acute Kidney Injury
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- University of Pittsburgh
- Enrolment target
- 2,145
- Started
- 5 September 2023
- Main results due
- 28 February 2028
- Study sites
- 9
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria:
1. Aged ≥ 18 years
2. Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements \>12 hours apart)
Exclusion Criteria:
1. AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
2. Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
1. Baseline estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m2
2. Previous kidney transplant recipient
3. On chronic dialysis
3. Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
4. Index hospitalization involving nephrectomy
5. Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
6. Continued dialysis dependence at time of discharge
7. Previous (within 6 months) or new referral to a nephrologist for care specifically for:
1. Previous or new diagnosis of glomerulonephritis
2. Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
3. Active treatment for acute interstitial nephritis
8. Non-kidney end-organ failure:
1. Class IV congestive heart failure
2. Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) \> 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
3. End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
9. Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
10. Primary goal of care is palliation: life expectancy \<6 months
11. Pregnancy
12. Vulnerable populations
1. Persons incarcerated
2. Persons institutionalized
13. Inability to provide informed consent
a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)
14. Concurrent enrollment in a separate greater than minimal risk interventional trial
15. Inability to participate in either in-person or remote visits
a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF)
16. Discharge to long-term acute care facility or other hospital-based locationWhat this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(9)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Yale University
New Haven, Connecticut, United States
Recruiting
Cleveland Clinic Weston Hospital
Weston, Florida, United States
Recruiting
University of Maryland
Baltimore, Maryland, United States
Recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Recruiting
MetroHealth
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
Nashville VA Medical Center
Nashville, Tennessee, United States
Recruiting
Vanderbilt University
Nashville, Tennessee, United States
Recruiting
Showing 9 of 9 sites. 9 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05805709. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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