Amino Acid Supplementation for Kidney Disease

(OASIS Trial)

Overseen By Subrata Debnath, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Amino acids, Antidepressants

Disqualifiers: COVID-19, Alcohol, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 17 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking amino acid supplements, antidepressants for major depressive disorder, or receiving active management for heart failure or anticancer therapy.

Is amino acid supplementation safe for people with kidney disease?

Research suggests that essential amino acid and ketoacid supplements are generally safe for people with kidney disease, as they can improve nutritional status and may help maintain kidney function without causing significant side effects. ^{1 2 3 4 5}

How does the treatment with essential amino acids and valine differ from other treatments for kidney disease?

This treatment is unique because it uses essential amino acids (EAAs) and their keto analogues (KAs) to support kidney function without adding extra nitrogen, which can be harmful in kidney disease. It helps maintain good nutrition and may delay the need for dialysis by reducing toxic metabolic products and managing mineral levels like potassium and phosphorus. ^{2 3 4 5 6}

What data supports the effectiveness of the treatment Essential Amino Acids for kidney disease?

Research shows that essential amino acids (EAA) can improve nutritional status and slow the progression of chronic kidney disease. In patients on hemodialysis, EAA supplementation led to clinical improvements such as increased body weight and better appetite. ^{1 2 3 6 7}

Who Is on the Research Team?

Subrata Debnath, PhD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-64 who have end-stage kidney disease and have been receiving in-clinic hemodialysis three times a week for at least six months. It's not specified who can't join, but typically those with other serious health issues or conditions that could interfere with the study might be excluded.

Inclusion Criteria

I am either male or female.

I have been on hemodialysis 3 times a week for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EAA or Valine supplementation on dialysis treatment days, followed by a washout period and crossover to the other supplement

17 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Essential Amino Acids
• Valine

Trial Overview The study aims to see if taking the amino acid valine alone or a mix of essential amino acids (EEA) can help reduce fatigue, frailty, and improve thinking skills in patients on hemodialysis due to severe kidney disease.

How Is the Trial Designed?

Group I: Treatment group Valine then EEA Experimental Treatment 2 Interventions

Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA

Group II: Treatment group EEA then Valine Experimental Treatment 2 Interventions

EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine

Essential Amino Acids is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Essential Amino Acids for:

• Nutritional deficiencies
• Malnutrition
• Wound healing

Approved in European Union as Essential Amino Acids for:

• Nutritional deficiencies
• Malnutrition
• Wound healing
• Parenteral nutrition

Approved in Canada as Essential Amino Acids for:

• Nutritional deficiencies
• Malnutrition
• Wound healing

Approved in Japan as Essential Amino Acids for:

• Nutritional deficiencies
• Malnutrition
• Wound healing

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

IIMS-UT Health San Antonio

Collaborator

Trials

2

Recruited

180+

Published Research Related to This Trial

In a comparison of essential amino acid (EAA) supplementation and keto-analogues (KA) in patients with chronic uremia, KA supplementation after EAA led to a reduction in urea levels and improved nitrogen balance across 9 studies.

Long-term KA treatment (3-9 months) in 7 patients resulted in notable improvements in renal function for some, with 5 patients remaining asymptomatic for periods of 3-8 months, suggesting potential benefits of KA in managing chronic kidney conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketoacids in the treatment of uremia. Walser, M.[2013]

In a study involving seven hemodialysis patients, administering 500 ml of a 5.5% essential amino acid solution during each dialysis session for 2 months led to a significant increase in albumin levels (p < 0.05).

The results suggest that this treatment could effectively improve nutritional status in hemodialysis patients, highlighting the potential benefits of essential amino acids in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The parenteral administration of essential amino acids in patients on periodic hemodialysis treatment. A pilot study]. Palestini, M., Nigro, A., Messina, A., et al.[2007]

In a study of 58 outpatients with elevated serum creatinine levels, a low protein diet supplemented with branched chain amino acids (BCKA) led to significant improvements in nutritional status and bone metabolism after 6 months, compared to those receiving essential amino acids (EAA).

Both groups experienced slowed progression of chronic renal failure, but the delay was more pronounced in the group receiving the BCKA supplement, indicating its potential superiority in managing renal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of two different essential amino acid/keto analogue preparations on the clinical status of patients with chronic renal failure. Meisinger, E., Strauch, M.[2019]

In a study of 15 patients with chronic renal failure, supplementation with essential amino acids (EAA) or alpha-keto acids (alpha-KA) did not show significant benefits beyond a low-protein diet of 0.55 g/kg, suggesting that such supplementation may be unnecessary for stable patients.

Alpha-KA supplementation did lead to a significant reduction in serum phosphate levels, indicating a potential benefit in managing phosphate levels, but overall, no major improvements in protein deficiency indicators were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of supplementation with essential amino acids and alpha-keto acids in the conservative management of patients with chronic renal failure. Hecking, E., Andrzejewski, L., Prellwitz, W., et al.[2019]

In a study of 15 patients with chronic renal failure undergoing hemodialysis, oral essential amino acid therapy (6.3 g/day) over 12.3 months led to significant clinical improvements, including increased body weight and serum albumin levels.

The therapy was well tolerated with no reported side effects, and patients experienced increased appetite and improved overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of oral essential amino acids in hemodialysis patients. Laorpatanaskul, S., Pochanugool, C., Sitprija, V.[2004]

Ketoacid (KA) analogues of essential amino acids (EAAs) can be beneficial for patients with advanced chronic kidney disease (CKD) by allowing amino acid conversion without adding extra nitrogen, which helps reduce toxic metabolic products and manage dietary restrictions on potassium and phosphorus.

Very-low-protein diets (VLPDs) supplemented with KAs and EAAs can maintain good nutrition and potentially delay the need for dialysis, but more research is needed to determine the optimal dosage and composition of these supplements, especially in patients with higher protein intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for ketoacid supplements in the management of CKD? Shah, AP., Kalantar-Zadeh, K., Kopple, JD.[2022]

In a controlled study involving uremic patients on a 30 g protein-restricted diet, a supplement with higher branched-chain keto acid (BCKA) content significantly improved renal function and bone metabolism.

Both types of supplements maintained the patients' nutritional status, highlighting the importance of BCKA content in dietary supplements for uremic patients on low protein diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled trial of two keto acid supplements on renal function, nutritional status, and bone metabolism in uremic patients. Meisinger, E., Strauch, M.[2007]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Ketoacids in the treatment of uremia. [2013]

2. Italy pubmed.ncbi.nlm.nih.gov

[The parenteral administration of essential amino acids in patients on periodic hemodialysis treatment. A pilot study]. [2007]

3. Germany pubmed.ncbi.nlm.nih.gov

The influence of two different essential amino acid/keto analogue preparations on the clinical status of patients with chronic renal failure. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

A controlled study of supplementation with essential amino acids and alpha-keto acids in the conservative management of patients with chronic renal failure. [2019]

5. Thailand pubmed.ncbi.nlm.nih.gov

The use of oral essential amino acids in hemodialysis patients. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Is there a role for ketoacid supplements in the management of CKD? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Controlled trial of two keto acid supplements on renal function, nutritional status, and bone metabolism in uremic patients. [2007]