NCT05805709 · University of Pittsburgh
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
(COPE-AKI)
What this study is about
The COPE-AKI study is a randomly assigned, pragmatic, parallel-treatment group$1 trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged ≥ 18 years
- 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
- AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
- Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
- Baseline estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m2
- Previous kidney transplant recipient
- On chronic dialysis
- Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
- Index hospitalization involving nephrectomy
- Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
- Continued dialysis dependence at time of discharge
- Previous (within 6 months) or new referral to a nephrologist for care specifically for:
- Previous or new diagnosis of glomerulonephritis
- Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
- Active treatment for acute interstitial nephritis
- Non-kidney end-organ failure:
- Class IV congestive heart failure
- Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) \> 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
- End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
- Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
- Primary goal of care is palliation: life expectancy \<6 months
- Vulnerable populations
- Persons incarcerated
- Persons institutionalized
- Inability to provide informed consent a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)
- Concurrent enrollment in a separate greater than minimal risk interventional trial
- 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)
- Discharge to long-term acute care facility or other hospital-based location
Where
- Birmingham, Alabama
- New Haven, Connecticut
- Weston, Florida
- Baltimore, Maryland
- Cleveland, Ohio
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations