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

NCT07169643 | Recruiting Phase 3

• 1 other identifier: EPO-LT Trial
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant; Complications

Keywords

living kidney trasplant

Outcome Measures

Primary Outcomes (1)

• to investigate the efficacy and safety of darbepoetin (DP) administration in patients on the liver transplant (LT) waiting list to reduce intraoperative red blood cell concentrate transfusion.

  Difference in the percentage of patients receiving intraoperative (LT) red blood cell transfusions between the intervention group and the control group.

  perioperative

Secondary Outcomes (20)

• Investigate the increase in hemoglobin levels

  through study completion, an average of 1 year

• Investigate the difference in the percentage of patients receiving intraoperative and during the first 24h after LT, red blood cell concentrate transfusion between the intervention and control groups

  baseline Visit , perioperative visit, month 3 postoperative

• Investigate the difference in the percentage of patients receiving intraoperative massive transfusion between the intervention and control groups.

  perioperative visit

• Investigate the difference in the percentage of patients who developed severe postoperative complications between the intervention and control groups.

  Difference in the 3-month severe postoperative complications

• Investigate the difference in the overall cost of the transplantation from surgery to three months post-transplant, between the intervention and control groups.

  three months post-transplant

Study Arms (2)

Darbepoetin arm

EXPERIMENTAL

Darbepoetin (DP) 1.5 mcg/kgsub cutaneously, 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)

Drug: Darbepoetin (DP)

No intervention arm

NO INTERVENTION

No administration darbepoetin(DP).

Interventions

Darbepoetin (DP) DRUG

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)

Darbepoetin arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patients on the official liver transplant waiting list
• Hemoglobin (Hb) level ≤ 11.5 g/dL
• A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. \*\* Sexual abstinence should only be used as a contraceptive method if it is in line with the subjects' usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not an acceptable method of contraception.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Annabel Blasi, Dr

  Fundació de Recerca Clínic Barcelona - Institut D'Investigacions Biomèdiques Agustí Pí i Sunyer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna cruceta, Dr

CONTACT

+93 2275400; acruceta@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manager

Model Details: This is a phase III, 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

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 12, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)