Post-Discharge Care for Acute Kidney Injury

(MAKE-IT Trial)

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+