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New treatment option for Acute Kidney Injury
Official title A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
ClinicalTrials.gov ID: NCT05805709
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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)
- 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
- Pregnancy
- 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 treatment 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...
- Discharge to long-term acute care facility or other hospital-based location
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- New Haven, Connecticut, United States
- Weston, Florida, United States
- Baltimore, Maryland, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; New Haven, Connecticut, United States; Weston, Florida, United States; Baltimore, Maryland, United States; Cleveland, Ohio, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.