Amino Acids for Acute Kidney Injury

(AKI Trial)

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Preoperative organ support, CKD, AKI

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether infusing amino acids can help children undergoing heart surgery who are at high risk of developing acute kidney injury. The goal is to determine if this treatment is safe and effective for these young patients. Participants will receive either amino acids or a placebo (a harmless substance with no treatment effect) for up to three days, starting at their surgery. Children undergoing cardiac surgery and considered high risk might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amino acids are generally safe for individuals undergoing heart surgery. Studies have found that administering amino acids through an IV can help protect the kidneys. For example, one study found that participants receiving amino acids had a lower risk of sudden kidney problems compared to those who did not. Specifically, 26.9% of individuals in the amino acid group experienced kidney issues, while 31.7% in the placebo group did.

This suggests that amino acids not only reduce the risk of kidney problems but are also well-tolerated. While no treatment is without risks, the evidence so far reassures those considering joining a trial involving amino acids. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using amino acids to treat acute kidney injury because they offer a potentially new way to support kidney function after cardiac surgery. Unlike traditional treatments that focus on managing symptoms or supporting kidney function indirectly, amino acids might provide a direct nutritional boost that helps the kidneys recover more quickly and effectively. This treatment could be particularly beneficial due to its straightforward approach and the potential for faster results, offering hope of reducing recovery time compared to existing options.

What evidence suggests that amino acids might be an effective treatment for acute kidney injury?

Research has shown that administering amino acids to patients during heart surgery can reduce the risk of sudden kidney problems, known as acute kidney injury (AKI). In this trial, some participants will receive amino acids for up to three days, beginning at the time of their cardiac surgery. One study found that patients who received amino acids were about 20% less likely to develop AKI compared to those who did not. Another study indicated that amino acids might improve blood flow and kidney function, helping to protect against AKI. These findings suggest that amino acids could effectively prevent kidney issues after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Shina Menon, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for pediatric patients at high risk who are undergoing cardiac surgery. It's not open to those with a history of acute kidney injury as indicated by serum creatinine levels, chronic kidney disease with specific low glomerular filtration rates, or any preoperative extracorporeal organ support.

Inclusion Criteria

I am having heart surgery and it's considered high risk.

Exclusion Criteria

History of serum creatinine defined preoperative acute kidney injury

My kidney function is reduced, with a GFR below 60 ml/min/1.73m2 in the last year.

I have had support from a machine for my organs before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either amino acids or placebo for up to 3 days starting at the time of their cardiac surgery

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amino Acids

Trial Overview The study is testing whether giving amino acids through an IV can help kids after heart surgery avoid kidney problems. Some will get the amino acids and others will get a placebo (a harmless substance that has no treatment effect) to compare outcomes.

How Is the Trial Designed?

Group I: Amino acid Experimental Treatment 1 Intervention

Participants receive amino acids for up to 3 days starting at the time of their cardiac surgery

Group II: Placebo Placebo Group 1 Intervention

Participants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38865168/

A Randomized Trial of Intravenous Amino Acids for Kidney ... Conclusions: Among adult patients undergoing cardiac surgery, infusion of amino acids reduced the occurrence of AKI.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924021478

WCN25-1885 Effectiveness of Amino Acid ... Amino acid supplementation significantly reduced the risk of AKI compared to the control group (RR = 0.80; 95% CI 0.66–0.97; p = 0.026; I2 = 28%).

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aas.70037?af=R

Effectiveness of amino acid supplementation in preventing ... Evidence suggests amino acid (AA) supplementation may enhance renal blood flow and glomerular filtration rate (GFR), potentially reducing AKI ...

4. academic.oup.com academic.oup.com/ckj/article/18/2/sfae409/7933326

Intravenous amino acid for kidney protection - Oxford Academic Intravenous amino acid administration, compared to placebo, significantly reduced the occurrence of AKI, providing the first level 1 evidence of an effective ...

5. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2403769

A Randomized Trial of Intravenous Amino Acids for Kidney ... Among adult patients undergoing cardiac surgery, infusion of amino acids reduced the occurrence of AKI.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0883944124004246

Protective effect of intravenous amino acid on kidney function A number of recent randomized controlled trials in cardiac surgery have found that intravenous amino acids significantly reduce the incidence of AKI [[14], [15 ...

7. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(24)01029-4/fulltext

Intravenous Amino-acid Infusion to Prevent Acute Kidney ... Intravenous AA therapy is the only proven treatment to prevent and/or attenuate the severity of cardiac surgery−associated AKI. Visual Abstract.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39447274/

Protective effect of intravenous amino acid on kidney function The results showed that compared with the control group, intravenous amino acid administration significantly reduced the incidence of AKI (RR: ...