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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

MAKE-IT Trial 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.Check my eligibility

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.See study design

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.

MAKE-IT Trial 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.

MAKE-IT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood pressure control

Number of incorrectly prescribed medicines

Proportion of individuals restarting RAAS inhibitors

+1 more

Secondary outcome measures

Major adverse kidney outcomes

MAKE-IT 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterOTHER

856 Previous Clinical Trials

672,172 Total Patients Enrolled

3 Trials studying Acute Kidney Injury

12,981 Patients Enrolled for Acute Kidney Injury

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,278,009 Total Patients Enrolled

9 Trials studying Acute Kidney Injury

2,917 Patients Enrolled for Acute Kidney Injury

University of KentuckyOTHER

185 Previous Clinical Trials

226,622 Total Patients Enrolled

3 Trials studying Acute Kidney Injury

2,352 Patients Enrolled for Acute Kidney Injury

Media Library

Acute Kidney Injury Clinical Trial 2023: Attending an Acute Kidney Injury Clinic Highlights & Side Effects. Trial Name: NCT04358874 — N/A

Attending an Acute Kidney Injury Clinic 2023 Treatment Timeline for Medical Study. Trial Name: NCT04358874 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is participation being sought for this research project?

"To participate in this research initiative, 120 eligible patients are required. These individuals can sign up at Vanderbilt University Medical Centre in Nashville and University of Kentucky in Lexington respectively."

Answered by AI

Are recruitment efforts still ongoing for this research project?

"Affirmative. Clinicaltrials.gov has corroborated that this clinical trial, which was initially posted on October 14th 2020, is currently enrolling individuals. Around 120 participants are needed from 3 distinct healthcare centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study

Orlando M. Gutierrez, MD, MMSc 2020. "Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04358874.