Liver Transplant; ComplicationsPhase 3EPO-LTNCT07169643
Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)
A Phase 3 study testing Darbepoetin (DP) in people with Liver Transplant; Complications, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Darbepoetin (DP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patients on the official liver transplant waiting list
- Hemoglobin (Hb) level ≤ 11.5 g/dL
- Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
- 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.
Who cannot join
- 1. Acute/subacute liver failure (see appendix 7) 2. Patients with acute-on-chronic liver failure grade III and/or MELD > 35 3. History of thrombosis, including portal vein thrombosis 4. Significant coronary artery disease (requiring angioplasty and/or coronary stent) 5. Serum ferritin > 800 ng/mL and SAT > 50% 6. Anticoagulant/antiplatelet therapy 7. History of seizures 8. Uncontrolled hypertension (requiring ≥2 antihypertensive drugs) 9. Active infection/sepsis (see appendix 8) 10. Lack of patient consent. 11. Pregnancy or breastfeeding. 12. Patients included in other clinical trials in the month before inclusion. 13. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
Anna Cruceta, MD, 0034 93 2279838, acruceta@clinic.cat
About this study
Official title: Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)
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.
Read the detailed description
Patients will be randomized to receive (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)
- 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
- Being tested
- Darbepoetin (DP)
- Keywords
- living kidney trasplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Darbepoetin (DP) |
| No intervention arm | No intervention | No administration darbepoetin(DP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: perioperative
Secondary outcomes (20)
Investigate the increase in hemoglobin levels
Absolute differences from baseline in hemoglobin levels basal and at 4, 8, 12 or 16 weeks after the administration of DP, or at the time of liver transplantation, between the intervention group and the control group
Measured: 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
Difference in the percentage of patients receiving intraoperative and during the first 24h after LT, red blood cell transfusions between the intervention group and the control group
Measured: 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.
Difference in the percentage of patients receiving massive transfusions(>6 units of red blood cells)
Measured: perioperative visit
Investigate the difference in the percentage of patients who developed severe postoperative complications between the intervention and control groups.
assessed by the Comprehensive Charlson Index, between groups
Measured: 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.
Difference in the overall cost (direct and indirect) of the transplantation, conducting a cost-effective analysis between groups
Measured: three months post-transplant
To evaluate the difference in postoperative graft survival , between groups
To evaluate the difference in the 3 month, 6, and 12 months, postoperative graft survival after liver transplantation, between groups
Measured: the 3 month, 6, and 12 months, postoperative graft survival after liver transplantation, between groups
To investigate the difference in the 3 month, 6, and 12 months, postoperative patient survival after liver transplantation, between groups
To evaluate the difference in the 3 month, 6, and 12 months, postoperative patients' survival after liver transplantation, between groups
Measured: in the 3 month, 6, and 12 months, postoperative patients survival after liver transplantation
Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the changes in the following coagulation marker beta-TG at basal and 4 weeks after administration
changes in the beta-TG marker (mg/mL)
Measured: at basal visit and month1
Impact of DP treatment on the changes in the PF4 profile of patients with chronic liver disease, comparing the changes in the fPF4 coagulation marker at basal and 4 weeks after administration
changes in the e PF4 (heprin antibody test ) in (IU/dL)
Measured: at basal visit and month1
Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the fibrinogen marker at basal and 4 weeks after administration
changes in the fibrinogen (g/L)
Measured: at basal visit and month1
Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the changes in theTM-TGA marker at basal and 4 weeks after administration
changes in the TM-TGA(ng/mL)
Measured: at basal visit and month1
Impact of DP treatment , comparing the changes in the following coagulation CTL marker at basal and 4 weeks after administration
changes in the CLT, (clothing and lysis time test ) (minutes) between groups
Measured: at basal visit and month1
Impact of DP treatment on the fibrinolitic profile of patients with chronic liver disease, comparing the changes iD dimer markers at basal and 4 weeks after administration
changes in the D dimer (micrograms/L) between groups
Measured: at basal visit and month1
Impact of DP treatment comparing the changes in the TAT marker at basal and 4 weeks after administration
changes in the TAT (trombi-antitrombin) (minutes), between groups
Measured: at basal visit and month1
Impact of DP treatment comparing the changes in the heptacidin marker at basal and 4 weeks after administration
changes in the hepcidin (nmol/dL), between groups
Measured: at basal visit and month1
Impact of DP treatment on the erythropoietin marker at basal and 4 weeks after administration
changes in the erythropoietin (mU/mL) between groups
Measured: at basal visit and month1
To explore the impact of anemia on complications of portal hypertension
the number and type of acute decompensations (acute gastrointestinal bleeding, infection,Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: through study completion, an average of 1 year
To explore the impact of the anemia on the quality of life measured by the EuroQol-5D scale , in both groups.
the quality of life measured by the EuroQol-5D scale of quality of live european
Measured: through study completion, an average of 1 year
To explore the predictors of poor response to DP treatment
defined as the increase in the hemoglobin level < 1 g/dL after 1 month of treatment.
Measured: base line visit, month 1, month 2, month 3, month 6.
Proportion of patients and severity of treatment-related adverse events during the study period,
Proportion of patients and severity of treatment-related adverse events during the study period,
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start25 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Annabel Blasi, Dr, Principal investigator, Fundació de Recerca Clínic Barcelona - Institut D'Investigacions Biomèdiques Agustí Pí i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169643
- Sponsor's protocol ID
- EPO-LT Trial
- Acronym
- EPO-LT
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)
- ClinicalTrials.gov ID
- NCT07169643
- Acronym / sponsor ID
- EPO-LT / EPO-LT Trial
- Conditions
- Liver Transplant; Complications
- Keywords
- living kidney trasplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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)
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin arm | Experimental | Drug: Darbepoetin (DP)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) |
| No intervention arm | No intervention | –No administration darbepoetin(DP). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Patients on the official liver transplant waiting list
- Hemoglobin (Hb) level ≤ 11.5 g/dL
- Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Key exclusion criteria (1 listed)
- 1. Acute/subacute liver failure (see appendix 7) 2. Patients with acute-on-chronic liver failure grade III and/or MELD > 35 3. History of thrombosis, including portal vein thrombosis 4. Significant coronary artery disease (requiring angioplasty and/or coronary stent) 5. Serum ferritin > 800 ng/mL and SAT > 50% 6. Anticoagulant/antiplatelet therapy 7. History of seizures 8. Uncontrolled hypertension (requiring ≥2 antihypertensive drugs) 9. Active infection/sepsis (see appendix 8) 10. Lack of patient consent. 11. Pregnancy or breastfeeding. 12. Patients included in other clinical trials in the month before inclusion. 13. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Darbepoetin arm |
Primary outcome
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.
Time frame: perioperative
Difference in the percentage of patients receiving intraoperative (LT) red blood cell transfusions between the intervention group and the control group.
20 secondary outcomes
Investigate the increase in hemoglobin levels
Time frame: 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
Time frame: 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.
Time frame: perioperative visit
Investigate the difference in the percentage of patients who developed severe postoperative complications between the intervention and control groups.
Time frame: 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.
Time frame: three months post-transplant
To evaluate the difference in postoperative graft survival , between groups
Time frame: the 3 month, 6, and 12 months, postoperative graft survival after liver transplantation, between groups
To investigate the difference in the 3 month, 6, and 12 months, postoperative patient survival after liver transplantation, between groups
Time frame: in the 3 month, 6, and 12 months, postoperative patients survival after liver transplantation
Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the changes in the following coagulation marker beta-TG at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment on the changes in the PF4 profile of patients with chronic liver disease, comparing the changes in the fPF4 coagulation marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the fibrinogen marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment on the hemostatic profile of patients with chronic liver disease, comparing the changes in theTM-TGA marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment , comparing the changes in the following coagulation CTL marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment on the fibrinolitic profile of patients with chronic liver disease, comparing the changes iD dimer markers at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment comparing the changes in the TAT marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment comparing the changes in the heptacidin marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
Impact of DP treatment on the erythropoietin marker at basal and 4 weeks after administration
Time frame: at basal visit and month1
To explore the impact of anemia on complications of portal hypertension
Time frame: through study completion, an average of 1 year
To explore the impact of the anemia on the quality of life measured by the EuroQol-5D scale , in both groups.
Time frame: through study completion, an average of 1 year
To explore the predictors of poor response to DP treatment
Time frame: base line visit, month 1, month 2, month 3, month 6.
Proportion of patients and severity of treatment-related adverse events during the study period,
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annabel Blasi, Dr principal investigator
Fundació de Recerca Clínic Barcelona - Institut D'Investigacions Biomèdiques Agustí Pí i Sunyer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin (DP) in people with Liver Transplant; Complications, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna cruceta, Dr (+93 2275400, acruceta@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.