NCT07169643

Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)

Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a national multicenter, randomized clinical trial to evaluate the the efficacy and safety of DP administration in patients on the liver transplant waiting list to reduce intraoperative red blood cell concentrate transfusion.

Detailed description

Patients will be randomized to receive (1:1): 1. Intervention group: Darbepoetin (DP) 1.5 mcg/kg subcutaneously, monthly (The patients will receive medication monthly until the liver transplant is performed or if it has not yet been transplanted, a maximum of 3 doses) 2. Control group: Do not Darbepoetin All patients will be evaluated to rule out vitamin B12 and folic acid deficiencies, and supplementation with 1000 mcg/day and 10 mg/day, respectively, will be provided if necessary. All patients, on the liver transplant list, will receive ferric carboxymaltose 1000 mg IV (every month) according to standard clinical practice Patients will be followed for 3 months after LT

Conditions

• Liver Transplant; Complications

Interventions

Type	Name	Description
DRUG	Darbepoetin (DP)	Darbepoetin (DP) 1.5 mcg/kg subcutaneously, monthly (The patients will receive medication monthly until the liver transplant is performed or if it has not yet been transplanted, a maximum of 3 doses)

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-09-12
• Last updated: 2025-12-18

Locations

1 site across 1 country: Spain