Acute Kidney InjuryMAKE-ITNCT04358874
Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
A study testing Medication reconciliation and Blood Pressure Management in people with Acute Kidney Injury, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care. 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?
- Medication reconciliation and Blood Pressure Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Oct 2020to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients age 18 years and older
- Patients who have developed moderate to severe AKI in the hospital, defined as:
- At least a doubling of peak creatinine from baseline or receipt of dialysis while in the hospital
- AKI of any degree in individuals with an estimated glomerular filtration (eGFR) rate < 60 ml/min/1.73m2 at baseline
- AKI of any degree whose discharge creatinine does not return to within 50% of baseline.
- Able to provide signed informed consent
Who cannot join
- Patients with a history of kidney transplant
- Patients who, in the opinion of the investigator, are not suitable to participate in the study
- Unable to obtain written informed consent
- prisoners or pregnant patients
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama
Birmingham, Alabama, 35294
University of Kentucky
Lexington, Kentucky, 40508
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.
Read the detailed description
Participants with moderate to severe acute kidney injury (AKI) who are discharged from participating centers (the University of Alabama at Birmingham Hospital, Vanderbilt University Medical Center, University of Kentucky) will be randomized to coming to a dedicated AKI clinic at one of the three recruitment centers for up to four visits over 3 months or usual care. At the visits to the AKI follow-up clinics, medicine reconciliation will be done, blood pressure will be measured, information on hospitalizations and other adverse events will be taken and blood and urine samples will be collected to check kidney function and store samples to measure biomarkers of AKI. Participants randomized to usual care will be contacted by telephone to review medications currently being taken and to collect information on hospitalizations and other adverse events. The primary outcome measures will be include both process of care and clinical outcomes.
- Conditions
- Acute Kidney Injury
- Being tested
- Medication reconciliation, Blood Pressure Management
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliationOther
Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.
Blood Pressure ManagementOther
Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)
| Study group | Role | What they receive |
|---|---|---|
| Active follow-up | Experimental | Participants randomized to the active follow-up arm will have follow-up visits in the AKI follow-up clinic every 4 weeks after discharge for a total of 90 days after discharge Receives: Other: Medication reconciliation; Other: Blood Pressure Management |
| Usual follow-up | Active comparator | Participants randomized to the usual follow-up arm will be called at home 4 weeks after the baseline visit to collect information on primary and secondary outcomes. Receives: Other: Medication reconciliation; Other: Blood Pressure Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incorrectly prescribed medicines
The number of incorrectly dosed or prescribed medications that are detected or changed
Measured: 90 days
Proportion of individuals restarting RAAS inhibitors
Proportion of patients with a class I indication for renin-angiotensin-aldosterone (RAAS) inhibitors who have appropriately re-started RAAS inhibitors within 3 months of discharge.
Measured: 90 days
Blood pressure control
Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.
Measured: 90 days
Recovery of kidney function
Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months
Measured: 90 days
Secondary outcomes (1)
Major adverse kidney outcomes
Defined as a composite of death, need for new dialysis, rehospitalization for AKI, recurrent AKI, or a persistent increase in baseline serum creatinine of ≥ 50%.
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 posted24 Apr 2020
- Study start14 Oct 2020
- Primary completion11 Oct 2021
- Study completion16 Dec 2024
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 Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of Kentucky
- Responsible party
- Principal investigator, Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358874
- Sponsor's protocol ID
- IRB-161201002
- Acronym
- MAKE-IT
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2020
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
- ClinicalTrials.gov ID
- NCT04358874
- Acronym / sponsor ID
- MAKE-IT / IRB-161201002
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, University of Kentucky
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 24 Apr 2020 (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.
This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.
Detailed description
Participants with moderate to severe acute kidney injury (AKI) who are discharged from participating centers (the University of Alabama at Birmingham Hospital, Vanderbilt University Medical Center, University of Kentucky) will be randomized to coming to a dedicated AKI clinic at one of the three recruitment centers for up to four visits over 3 months or usual care. At the visits to the AKI follow-up clinics, medicine reconciliation will be done, blood pressure will be measured, information on hospitalizations and other adverse events will be taken and blood and urine samples will be collected to check kidney function and store samples to measure biomarkers of AKI. Participants randomized to usual care will be contacted by telephone to review medications currently being taken and to collect information on hospitalizations and other adverse events. The primary outcome measures will be include both process of care and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active follow-up | Experimental | Other: Medication reconciliation, Other: Blood Pressure ManagementParticipants randomized to the active follow-up arm will have follow-up visits in the AKI follow-up clinic every 4 weeks after discharge for a total of 90 days after discharge |
| Usual follow-up | Active comparator | Other: Medication reconciliation, Other: Blood Pressure ManagementParticipants randomized to the usual follow-up arm will be called at home 4 weeks after the baseline visit to collect information on primary and secondary outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients age 18 years and older
- Patients who have developed moderate to severe AKI in the hospital, defined as:
- Able to provide signed informed consent
Key exclusion criteria (4 listed)
- Patients with a history of kidney transplant
- Patients who, in the opinion of the investigator, are not suitable to participate in the study
- Unable to obtain written informed consent
- prisoners or pregnant patients
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 |
|---|---|---|
| Medication reconciliationMedicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge. | Other | Active follow-up, Usual follow-up |
| Blood Pressure ManagementBlood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100) | Other | Active follow-up, Usual follow-up |
Primary outcome
Number of incorrectly prescribed medicines
Time frame: 90 days
The number of incorrectly dosed or prescribed medications that are detected or changed
Proportion of individuals restarting RAAS inhibitors
Time frame: 90 days
Proportion of patients with a class I indication for renin-angiotensin-aldosterone (RAAS) inhibitors who have appropriately re-started RAAS inhibitors within 3 months of discharge.
Blood pressure control
Time frame: 90 days
Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.
Recovery of kidney function
Time frame: 90 days
Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months
1 secondary outcome
Major adverse kidney outcomes
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reconciliation and Blood Pressure Management in people with Acute Kidney Injury, run by University of Alabama at Birmingham at 3 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incorrectly prescribed medicines (time frame: 90 days). The study lists 4 primary outcomes in all. 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 19 Dec 2024.