Post-Discharge Care for Acute Kidney Injury

(MAKE-IT Trial)

No longer recruiting at 2 trial locations

Overseen By Orlando Gutierrez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Kidney transplant, Prisoners, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the benefits of attending a special clinic after hospital discharge for individuals with severe kidney problems. Researchers aim to determine if clinic visits improve medication management, blood pressure, and kidney recovery compared to not attending. Participants will be divided into two groups: one attending regular follow-up visits at the clinic and another having regular check-ins over the phone. Candidates may qualify if they recently experienced severe kidney issues in the hospital and their kidney function hasn't fully recovered before discharge. As an unphased study, this trial offers a unique opportunity to contribute to important research that could enhance recovery care for kidney patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What prior data suggests that attending an Acute Kidney Injury Clinic is safe?

Research has shown that follow-up care for individuals who have experienced acute kidney injury (AKI) is crucial for recovery. Studies have found that clinic visits after hospital discharge can help prevent further kidney issues. Researchers tracked safety outcomes, such as avoiding hospital readmissions due to kidney problems, for up to a year post-discharge. This follow-up care is generally well-received and may reduce the risk of future complications. Overall, attending an AKI clinic appears to be a safe and effective method to support recovery and manage health after an AKI event. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about post-discharge care for Acute Kidney Injury (AKI) because it introduces a proactive approach to managing recovery. Unlike the usual follow-up, which involves a one-time call to assess outcomes, the active follow-up treatment provides regular, in-person visits to a specialized AKI clinic every four weeks for 90 days post-discharge. This method allows for consistent monitoring and early intervention, potentially improving recovery and reducing the risk of further kidney damage. The excitement stems from the possibility of improving patient outcomes through more personalized and frequent care.

What evidence suggests that attending an Acute Kidney Injury Clinic could be effective for post-discharge care?

Research shows that visiting an Acute Kidney Injury (AKI) clinic after hospital discharge can benefit patients. In this trial, participants in the active follow-up arm will visit the AKI follow-up clinic every 4 weeks for a total of 90 days. Studies have found that follow-up care within this period can aid kidney recovery and prevent further damage. A large study in Canada found a 24% lower risk of death for those with severe AKI who regularly saw a kidney specialist. Another study showed that patients who attended these clinics had a better understanding of their condition. Overall, these clinics improve recovery and health outcomes for AKI survivors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had moderate to severe acute kidney injury (AKI) in the hospital. Participants should have experienced at least a doubling of their baseline creatinine levels or received dialysis. It's also open to those with lower baseline kidney function or whose kidneys haven't recovered well by discharge time. People with kidney transplants, prisoners, pregnant individuals, and anyone deemed unsuitable by the investigator can't join.

Inclusion Criteria

Able to provide signed informed consent

I developed moderate to severe kidney injury while in the hospital.

My kidney function has worsened significantly or I've needed dialysis.

Exclusion Criteria

Unable to obtain written informed consent

Patients who, in the opinion of the investigator, are not suitable to participate in the study

I have had a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either attend an AKI clinic for up to four visits over 3 months or receive usual care with telephone follow-up.

12 weeks

4 visits (in-person) for AKI clinic group, telephone follow-up for usual care group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medication review and adverse event collection.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attending an Acute Kidney Injury Clinic
• Blood Pressure Management
• Medication Reconciliation

Trial Overview The MAKE-IT Study is testing if attending an AKI clinic after leaving the hospital helps patients manage their medications better, control blood pressure more effectively, and recover kidney function compared to standard care they would normally receive.

How Is the Trial Designed?

Group I: Active follow-up Experimental Treatment 2 Interventions

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

Group II: Usual follow-up Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034506/

Acute Kidney Injury Survivor Care Following Hospital ... Widespread delivery of high-quality care for acute kidney injury (AKI) survivors after hospital discharge requires a multidisciplinary team.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949813925000059

Article Postdischarge Care of Acute Kidney Injury Survivors Postdischarge follow-up for AKI survivors is recommended within 90 days of an AKI episode to promote kidney recovery and potentially prevent progression of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11003554/

Effectiveness of Multidisciplinary Post-Acute Kidney Injury ... The purpose of the study was to evaluate the impact of a multidisciplinary post-AKI clinic on AKI awareness and knowledge among survivors.

4. ajkd.org ajkd.org/article/S0272-6386(22)01052-6/fulltext

Association of an Acute Kidney Injury Follow-up Clinic With ... Propensity scores were used to match each patient who attended an AKI follow-up clinic to 4 patients who received standard care.

5. journals.lww.com journals.lww.com/jasn/fulltext/2025/03000/advancing_community_care_and_access_to_follow_up.14.aspx

Advancing Community Care and Access to Follow-Up after... Data from a population-based cohort in Ontario, Canada, suggested a 24% lower incidence of death for patients with severe AKI who received nephrology follow-up ...

6. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/9/4/e000891

Post-discharge care following acute kidney injury Illness complicated by AKI is common and is associated with adverse outcomes including high rates of unplanned hospital readmission. Through ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8786140/

Post-Discharge Mortality and Rehospitalization among ... Using innovative, patient-centered interventions, 68% of eligible high-risk patients with AKI were enrolled and all came to nephrology follow-up.