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

Recruiting

Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial

Who can join

Ages 18 and older · All sexes

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 location

About the study

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.

What is being tested

Sponsor: University of Pittsburgh · Participants: 2,145 · Started: Sep 5, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05805709

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ConnecticutYale University, New Haven
FloridaCleveland Clinic Weston Hospital, Weston
MarylandJohns Hopkins University, Baltimore
University of Maryland, Baltimore
OhioCleveland Clinic Foundation, Cleveland
MetroHealth, Cleveland
TennesseeNashville VA Medical Center, Nashville
Vanderbilt University, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.