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Conservative Dialysis Approach for Acute Kidney Injury (LIBERATE-D Trial)

N/A

Recruiting

Led By Kathleen Liu, MD, PhD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Hemodynamic stability: not requiring vasopressor support and with planned intermittent dialysis

≥ 18 years of age

Must not have

Decompensated heart failure requiring left ventricular assist device or continuous inotropic support

Nontraditional indication for dialysis (end-stage liver disease awaiting transplantation, fulminant hepatic failure, intoxication)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to date of death from any cause, assessed up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a more conservative approach to dialysis improves outcomes for patients with acute kidney injury who require dialysis.

Who is the study for?

This trial is for adults over 18 with acute kidney injury needing dialysis, who are stable without vasopressor support and have a history of good kidney function. It's not for pregnant individuals, prisoners, those unable to consent or lacking a decision-maker, patients with certain other health conditions or treatments, or if they've been on dialysis for more than 3 months.

What is being tested?

The LIBERATE-D study is testing whether less frequent dialysis (a conservative strategy) can be as effective as the standard three times weekly sessions in helping patients recover from acute kidney injury that required initial dialysis treatment.

What are the potential side effects?

Potential side effects may include complications related to reduced frequency of dialysis such as fluid overload, increased levels of waste products in the blood like urea and creatinine, electrolyte imbalances, and potential delays in recovery of kidney function.

Eligibility Criteria

Inclusion Criteria

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

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I don't need drugs to maintain my blood pressure and I am scheduled for occasional dialysis.

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I am 18 years old or older.

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I am hospitalized with acute kidney injury requiring dialysis, as diagnosed by my kidney doctor.

Exclusion Criteria

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

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I need a device or continuous medication to support my heart's pumping.

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I need dialysis for reasons other than kidney failure, like liver disease.

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My kidney was removed and it caused acute kidney injury.

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I need a lot of oxygen support to keep my oxygen levels above 95%.

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I received a kidney transplant during my current hospital stay.

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I cannot give consent and have no one to make decisions for me.

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I have been on dialysis for more than 3 months.

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I am on a breathing machine through a tube in my windpipe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to date of death from any cause, assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to date of death from any cause, assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to date of death from any cause, assessed up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients with renal recovery at hospital discharge

Secondary study objectives

Dialysis-free days to study day 28

Number of dialysis sessions/week

Other study objectives

All-cause day 28 mortality

All-cause day 90 mortality

All-cause in-hospital mortality

+5 more

Side effects data

From 2013 Phase 4 trial • 86 Patients • NCT01156363

33%

Hypertension

28%

Cough

27%

Upper respiratory tract infection

19%

Constipation

16%

Abdominal pain upper

16%

Headache

16%

Pruritus

15%

Hyperkalaemia

15%

Hyperphosphataemia

14%

Procedural hypotension

14%

Oedema peripheral

14%

Insomnia

13%

Diarrhoea

13%

Muscle spasms

13%

Rhinorrhoea

12%

Dizziness

10%

Nasopharyngitis

10%

Oropharyngeal pain

10%

Productive cough

Hyperparathyroidism

Urinary tract infection

Haemodialysis complication

Regurgitation

Hypotension

Abdominal distension

Contusion

Pyrexia

Procedural hypertension

Wound

Dermatitis

Acute myocardial infarction

Gastric ulcer

Alcoholic liver disease

Respiratory tract infection

Septic shock

Fracture

Chronic hepatitis

Abdominal infection

Bladder cancer recurrent

Urinary incontinence

Acute respiratory failure

Haemoptysis

Cardiac failure congestive

Bacteraemia

Bronchopneumonia

Pharyngitis

Septic embolus

Diabetes mellitus inadequate control

Muscular weakness

Hepatic encephalopathy

Acute pulmonary oedema

Pleural effusion

Pulmonary haemorrhage

Arteriovenous fistula operation

Labile blood pressure

100%

80%

60%

40%

20%

Study treatment Arm

Mircera

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: ConservativeExperimental Treatment1 Intervention

Conservative dialysis strategy--dialysis prescribed only when specific metabolic or clinical indications are met. These indications are: blood urea nitrogen \>112 mg/dL (40 mmol/L; blood potassium concentration \>6 mmol/L; blood potassium concentration \>5.5 mmol/L despite medical treatment; arterial blood gas pH \<7.15, or in the absence of an available blood gas, serum bicarbonate \<12 mmol/L, acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate \>5 L/min or equivalent via face mask/tracheostomy mask to maintain SpO2 \>95% or requiring FiO2 \>50% in patients with tracheostomy already on invasive or non-invasive mechanical ventilation and despite diuretic therapy; clinician judgement

Group II: ConventionalActive Control1 Intervention

Thrice-weekly intermittent dialysis until pre-specified criteria for recovery are met

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dialysis

2008

Completed Phase 4

~160

0 / 11Eligibility criteria met