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Post-Discharge Care for Acute Kidney Injury (MAKE-IT Trial)

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients with a history of kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the outcomes of patients who are discharged from the hospital after acute kidney injury and either attend an AKI clinic or receive usual care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include issues related to blood pressure management such as dizziness or lightheadedness and reactions from medication adjustments like allergic responses or gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

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My kidney function has not fully recovered after injury.

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I have kidney injury and my kidney function is low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure control

Number of incorrectly prescribed medicines

Proportion of individuals restarting RAAS inhibitors

+1 more

Secondary study objectives

Major adverse kidney outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active follow-upExperimental Treatment2 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-upActive Control2 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.

0 / 6Eligibility criteria met