In short
L-isoleucine is an essential amino acid, one of the building blocks of proteins. As part of a fixed-combination amino acid solution called Nephrotect, it is being studied in a Phase 3 clinical trial to see how it affects kidney function in living kidney donors and transplant recipients. The trial, authorised in the EU, plans to enrol 60 participants.
Key points
- L-isoleucine is an essential amino acid used in a fixed-combination infusion solution called Nephrotect.
- The solution is being tested in a Phase 3 trial involving living kidney donors and transplant recipients.
- The trial plans to enrol 60 participants and is currently authorised.
- The study measures kidney function using plasma clearance of iohexol and assesses renal reserve.
- Nephrotect is an authorised medicine in Spain, supplied by Fresenius Kabi Deutschland GmbH.
What is l-isoleucine?
L-isoleucine is an essential amino acid, meaning the body cannot make it and it must come from food or supplements. It is one of the branched-chain amino acids, along with leucine and valine.
How does l-isoleucine work?
Amino acids such as l-isoleucine are the building blocks of proteins. They are used by the body for growth, repair of tissues, and many metabolic functions. In the transplant trial, an intravenous infusion of an amino acid solution containing l-isoleucine is used to assess renal reserve, which is the kidney's capacity to increase its filtration rate under stress. The mechanism by which amino acid infusion stimulates kidney function is not described in detail in the trial record.
Which conditions is it used or studied for?
- Renal transplantation, living donor — The trial studies how pre-donation kidney function and renal reserve in living donors affect the evolution of kidney function after transplantation in both donors and recipients.
How is l-isoleucine given?
In the clinical trial, l-isoleucine is given as part of Nephrotect, a solution for infusion administered by intravascular use. The trial uses 840 millilitres of the solution per infusion. In Canada, l-isoleucine is allowed for oral use as a flavour enhancer and for topical use as a skin-conditioning agent at up to 0.002%.
What do the clinical trials show?
The EU Clinical Trials Information System lists one clinical trial involving this fixed-combination amino acid solution. The trial is a Phase 3 interventional study with a planned enrolment of 60 participants and is currently authorised.
The primary outcome is the evolution of renal function in the donor and recipient after renal transplantation. Renal function is measured with a reference standard, plasma clearance of iohexol. Renal reserve is assessed by intravenous infusion of the amino acid solution.
What side effects are known?
The trial record does not list specific side effects for Nephrotect. The Canadian source for l-isoleucine does not report side effects for the oral or topical uses described.