In short
L-valine is a branched-chain essential amino acid that promotes muscle growth and tissue repair. It is being studied as part of a fixed amino acid combination product (Nephrotect solution for infusion) in one Phase 3 clinical trial involving 60 participants to assess whether measuring a living kidney donor's renal reserve before transplantation can predict kidney function after transplantation in both donor and recipient.
Key points
- L-valine is a branched-chain essential amino acid and a precursor in the penicillin biosynthetic pathway.
- It is one of 17 amino acids in Nephrotect solution for infusion, a combination product authorised in Spain.
- One Phase 3 clinical trial is studying how pre-donation renal reserve relates to post-transplant kidney function.
- The trial includes 60 participants and is currently authorised but not yet recruiting.
- The primary outcome is renal function evolution measured by plasma clearance of iohexol in donors and recipients.
- L-valine is also available as an oral powder and oral solution in some product listings.
What is l-valine?
L-valine is a branched-chain essential amino acid, meaning the body cannot make it on its own and it must be obtained from food or supplements.
How does l-valine work?
As a branched-chain amino acid, l-valine is involved in protein synthesis and is used by the body to build and repair muscle tissue. In the context of the registered trial, l-valine is not being studied for its own direct effect on a disease. Instead, it forms part of an amino acid solution that is infused intravenously to assess renal reserve — the kidney's capacity to increase its filtration rate in response to a stimulus. The solution is used as a diagnostic tool to measure how well a kidney can respond to an amino acid load. DrugCentral notes that l-valine has stimulant activity and is a precursor in the penicillin biosynthetic pathway.
Which conditions is l-valine used or studied for?
- Renal transplantation, living donor — L-valine as part of Nephrotect solution is being studied in a Phase 3 trial to evaluate how the renal function and renal reserve of a living kidney donor before transplantation relate to kidney function after transplantation in both the donor and the recipient.
How is l-valine given?
In the registered trial, l-valine is given as part of Nephrotect solution for infusion, administered by intravascular use (into a vein) in a volume of 840 millilitres. The NHS dm+d browser also lists several oral forms of valine as virtual medicinal products, including Valine 50 oral powder 4g sachets, Valine 2.5g oral powder sachets, Valine 50mg/5ml oral solution, and Valine 50mg/ml oral solution sugar free.
What do the clinical trials show?
One Phase 3 interventional trial (EU CT number 2024-519757-11-00) is registered in the EU Clinical Trials Information System. It is currently authorised but has not reported results. The trial plans to enrol 60 participants and is titled "Predonation renal reserve: impact on the evolution of donor and recipient renal function in a living donor renal transplantation programme".
The primary outcome is the evolution of renal function measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol, and renal reserve will be assessed by intravenous infusion of an amino acid solution containing l-valine.
What side effects are known?
The provided sources do not report specific side effects for l-valine or Nephrotect solution for infusion. Therefore, a side effects section cannot be completed from the available data.