Acute Kidney InjuryCOPE-AKINCT05805709
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
A study testing Study Physician/Advance Practice Provider, Nurse Navigator and Pharmacist in people with Acute Kidney Injury, run by University of Pittsburgh at 9 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Study Physician/Advance Practice Provider, Nurse Navigator and Pharmacist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,145 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Sep 2023to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 29Show fewer
- 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
- 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
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kaleab Abebe, PhD contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Tramanh Phan, MD, TPhan@som.umaryland.edu
Matthew Weir, MD
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Pam Corona, MD, pamelacorona@jhmi.edu
Chirag Parikh, MD PhD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Patricia Busta
Javier Neyra, MD
- Recruiting
MetroHealth
Cleveland, Ohio, 44109
Kyra Jancik, KJancik@metrohealth.org
Edward Horwitz, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Savannah Gagnon, BS
Emilio Poggio, MD
- Recruiting
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637
Jasiu Latocha, john.latocha@vumc.org
Eddie Siew, MD
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Ethan Kefauver, BS, ethan.kefauver@vumc.org
Edward Siew, MD
- Recruiting
Yale University
New Haven, Connecticut, 06510
Angela V Castro, MD, angela.victoria-castro@yale.edu
Francis Wilson, MD
- Recruiting
Cleveland Clinic Weston Hospital
Weston, Florida, 33331
Laura Duarte, DUARTEL2@ccf.org
Scott Cohen, MD
About this study
Official title: Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial
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.
Read the detailed description
The primary study hypotheses for the COPE-AKI study are: compared to usual care, patients randomized to a multimodal intervention will have increased odds of more hospital-free days through 90 days (primary) and lower rates of major adverse kidney events (MAKE) at 180 days, lower rates of recurrent AKI at 180 days, and greater improvements in patient-reported outcomes over 90 days (secondary).
The primary outcome is hospital-free days through 90 days of follow up, defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status, based on the determination made by the corresponding hospital. Key secondary outcomes include: rates of MAKE (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and 4 patient-report outcomes: global health related quality of life, AKI-specific health related quality of life, provider interactions, and social support (30, 90, 180, 365 days).
A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. Participants in the usual care arm will be provided information about their kidney disease, nephrotoxins to be avoided, and the importance of follow up with a physician will be emphasized.
- Conditions
- Acute Kidney Injury
- Being tested
- Study Physician/Advance Practice Provider, Nurse Navigator, Pharmacist, Patient Education
- Keywords
- acute kidney injury, process of care, acute renal failure, kidney failure, kidney damage, pragmatic, nurse navigator, pharmacist
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Physician/Advance Practice ProviderOther
The nephrologist and/or nephrology-associated advanced practice provider (APP) at each site will lead the intervention team for the duration of the study. The study physicians will fulfil two main roles: (a) Provide supervision to the rest of the study team and (b) conduct a discharge assessment to triage and make recommendations for follow-up care.
Nurse NavigatorOther
The nurse navigator will be the primary contact for the participants assigned to the intervention group for the study. The navigator will obtain contact information, information about the patient's usual care providers and pharmacy, review medications, show the participant how to use the home blood pressure machine and scales and arrange for follow-up visits. The role of the nurse navigator will be to monitor the participant's medical condition; facilitate scheduling of needed medical follow-up including both routine (pre-scheduled) and ad hoc (urgent or emergency); enhance adherence with prescribed medical care and follow-up appointments; and serve as a resource to the patient to answer questions about their AKI-related management, facilitate medical and associated care and provide enhanced psychosocial support.
PharmacistOther
The pharmacist will complete the medication reconciliation and medication regimen review per the predetermined checklist, via telemedicine if agreeable to the patient. The goal of the patient/caregiver-pharmacist interaction is to cover the following: avoidance of nephrotoxins when possible and appropriate, appropriate dosing of renally cleared drugs, review for drug-drug interactions, monitoring appropriate use of chronic medications, medication adherence, monitor for adverse drug reactions, evaluation of non-prescription medication use, medication/disease education and social support.
Patient EducationOther
Written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Process of Care Intervention | Experimental | A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. Receives: Other: Study Physician/Advance Practice Provider; Other: Nurse Navigator; Other: Pharmacist; Other: Patient Education |
| Usual Care | Active comparator | After receiving the same written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician as individuals randomized to the multimodal intervention arm, participants randomized to the control arm will receive usual care as specified by their treating providers and will not be followed by nurse navigator, pharmacist, or the study team. The only subsequent study-related activities will be the follow-up study visits for ascertainment of endpoints with the research coordinator. Receives: Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-Free Days (HFDs) through day 90
Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.
Measured: 90 days
Secondary outcomes (6)
Rate of Major Adverse Kidney Events (MAKE) at 180 days
MAKE-180 composite outcome of death, dialysis and assessment of kidney function defined as:
- death within 180 days of index hospital discharge;
- need for dialysis at 180 days after index hospital discharge; or
- serum creatinine >2x baseline at 180 days after index hospital discharge
Measured: 180 days
Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days
Episodes of recurrent AKI during subsequent all-cause hospitalizations will be adjudicated based on hospitalization data, defining recurrent episodes of AKI based on an increase in serum creatinine of >50% relative to the lowest-known value preceding or including the rehospitalization.
Measured: 180 days
Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 90 days.
HR-QOL will be assessed with the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) HRQoL measure. The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health, which are rescaled into a standardized score (T-score) with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher T-score represents more of the concept being measured. Thus, a person who has T-scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population.
Measured: 90 days
Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 90 days.
AKI-Specific HR-QOL will be assessed with the 6-item Chronic Kidney Disease Quality of Life (CKD-QoL) measure. The CKD-QoL comprehensively represents CKD-specific quality of life and yields a single summary impact score. Norm-based scoring is used (linearly transformed to have a mean of 50 and an SD of 10) in which a higher score indicates worse QOL impact.
Measured: 90 days
Change from baseline in Interactions with Providers at 90 days.
Provider interactions will be assessed with the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) and 8-item Client Satisfaction Questionnaire (CSQ-8) measures. The PEPPI provides a summary score ranging for 5 to 25 (25 = sighted patient self-efficacy). The CSQ-8 is a structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Measured: 90 days
Change from baseline in Social Support at 90 days.
Social support will be assessed with the 4-item PROMIS Emotional Support and 4-item PROMIS Instrumental Support short forms. The Emotional Support and Instrumental Support measures each produce a summary score, which are rescaled into a standardized score (T-score) with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher T-score represents more of the concept being measured. Thus, a person who has a T-score of 60 is one standard deviation better (more healthy) than the general population.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start5 Sep 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, pragmatic, parallel-arm kidney trial conducted to find out if an "enhanced care" team approach can improve a patient's outcomes after hospitalization with acute kidney injury (AKI). 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaleab Abebe, PhD, University of Pittsburgh
- Investigators
- Kaleab Abebe, PhD, Principal investigator, Univerisity of PittsburghLinda Fried, MD, Principal investigator, University of PittsburghPaul Palevsky, MD, Principal investigator, University of PittsburghSandy Kane-Gill, PharmD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805709
- Sponsor's protocol ID
- STUDY21080024
- Other IDs
- 1U01DK130010, 1U01DK129989, 1U01DK129980, 1U01DK129984
- Acronym
- COPE-AKI
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the University of Pittsburgh Data Coordinating Center (DCC). This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by the DCC research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial
- ClinicalTrials.gov ID
- NCT05805709
- Acronym / sponsor ID
- COPE-AKI / STUDY21080024
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, process of care, acute renal failure, kidney failure, kidney damage, pragmatic, nurse navigator, pharmacist
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,145 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary study hypotheses for the COPE-AKI study are: compared to usual care, patients randomized to a multimodal intervention will have increased odds of more hospital-free days through 90 days (primary) and lower rates of major adverse kidney events (MAKE) at 180 days, lower rates of recurrent AKI at 180 days, and greater improvements in patient-reported outcomes over 90 days (secondary).
The primary outcome is hospital-free days through 90 days of follow up, defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status, based on the determination made by the corresponding hospital. Key secondary outcomes include: rates of MAKE (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and 4 patient-report outcomes: global health related quality of life, AKI-specific health related quality of life, provider interactions, and social support (30, 90, 180, 365 days).
A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. Participants in the usual care arm will be provided information about their kidney disease, nephrotoxins to be avoided, and the importance of follow up with a physician will be emphasized.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, pragmatic, parallel-arm kidney trial conducted to find out if an "enhanced care" team approach can improve a patient's outcomes after hospitalization with acute kidney injury (AKI). 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.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Process of Care Intervention | Experimental | Other: Study Physician/Advance Practice Provider, Other: Nurse Navigator, Other: Pharmacist, Other: Patient EducationA multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. |
| Usual Care | Active comparator | Other: Patient EducationAfter receiving the same written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician as individuals randomized to the multimodal intervention arm, participants randomized to the control arm will receive usual care as specified by their treating providers and will not be followed by nurse navigator, pharmacist, or the study team. The only subsequent study-related activities will be the follow-up study visits for ascertainment of endpoints with the research coordinator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (29 listed)
- AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
- Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Physician/Advance Practice ProviderThe nephrologist and/or nephrology-associated advanced practice provider (APP) at each site will lead the intervention team for the duration of the study. The study physicians will fulfil two main roles: (a) Provide supervision to the rest of the study team and (b) conduct a discharge assessment to triage and make recommendations for follow-up care. | Other | Multimodal Process of Care Intervention |
| Nurse NavigatorThe nurse navigator will be the primary contact for the participants assigned to the intervention group for the study. The navigator will obtain contact information, information about the patient's usual care providers and pharmacy, review medications, show the participant how to use the home blood pressure machine and scales and arrange for follow-up visits. The role of the nurse navigator will be to monitor the participant's medical condition; facilitate scheduling of needed medical follow-up including both routine (pre-scheduled) and ad hoc (urgent or emergency); enhance adherence with prescribed medical care and follow-up appointments; and serve as a resource to the patient to answer questions about their AKI-related management, facilitate medical and associated care and provide enhanced psychosocial support. | Other | Multimodal Process of Care Intervention |
| PharmacistThe pharmacist will complete the medication reconciliation and medication regimen review per the predetermined checklist, via telemedicine if agreeable to the patient. The goal of the patient/caregiver-pharmacist interaction is to cover the following: avoidance of nephrotoxins when possible and appropriate, appropriate dosing of renally cleared drugs, review for drug-drug interactions, monitoring appropriate use of chronic medications, medication adherence, monitor for adverse drug reactions, evaluation of non-prescription medication use, medication/disease education and social support. | Other | Multimodal Process of Care Intervention |
| Patient EducationWritten information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician will be provided. | Other | Multimodal Process of Care Intervention, Usual Care |
Primary outcome
Hospital-Free Days (HFDs) through day 90
Time frame: 90 days
Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.
6 secondary outcomes
Rate of Major Adverse Kidney Events (MAKE) at 180 days
Time frame: 180 days
Recurrent Acute Kidney Injury (AKI) Hospitalization at 180 days
Time frame: 180 days
Change from baseline in Global Health-Related Quality of Life (HR-QoL) at 90 days.
Time frame: 90 days
Change from baseline in AKI-Specific Health-Related Quality of Life (HR-QoL) at 90 days.
Time frame: 90 days
Change from baseline in Interactions with Providers at 90 days.
Time frame: 90 days
Change from baseline in Social Support at 90 days.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the University of Pittsburgh Data Coordinating Center (DCC). This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by clinical sites and by the DCC research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaleab Abebe, PhD contact
Kaleab Abebe, PhD principal investigator
Univerisity of Pittsburgh
Linda Fried, MD principal investigator
University of Pittsburgh
Paul Palevsky, MD principal investigator
University of Pittsburgh
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Physician/Advance Practice Provider, Nurse Navigator and Pharmacist in people with Acute Kidney Injury, run by University of Pittsburgh at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan J Copelli, MSHI (412-245-0803, sju1@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-Free Days (HFDs) through day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.