Study on the Impact of Acetylcysteine and Drug Combination on Kidney Function in Living Donor Kidney Transplant Patients
- Participants:Adults · Healthy volunteers
Rare diseases
Investigational molecules
Locations
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.
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.[1] DrugCentral notes that l-valine has stimulant activity and is a precursor in the penicillin biosynthetic pathway.[3]
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.[1] 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.[2]
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".[1]
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.[1]
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.
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