AnemiaPhase 4L-CAR-ESANCT07160452
Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia
A Phase 4 study testing Levocarnitine Injection and Usual ESA-Based Anemia Care in people with Anemia and Kidney Failure, run by Shaikh Zayed Hospital, Lahore.
Trial summary
Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anemia, Kidney Failure, End-Stage Renal Disease
- What is being tested?
- Levocarnitine Injection and Usual ESA-Based Anemia Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Mar 2026
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female patients
- Patients aged 20-60 years.
- Patients undergoing maintenance hemodialysis three times a week for at least six months
- Patients having renal anemia
Who cannot join
- Patients currently using any carnitine preparation as a supplement (to avoid confounding effects from additional carnitine intake).
- Patients on immunosuppressive drugs, steroids, or antibiotics (to avoid the influence of these medications on anemia and carnitine metabolism).
- Patients who have previously received levocarnitine in either oral or injected form (to eliminate any prior influence of levocarnitine on study outcomes).
- Patients with a history of blood transfusion within the past 6 months (to exclude the immediate impact of transfusions on hemoglobin levels and anemia management).
- Patients with acute inflammation (to prevent interference with study parameters as inflammation can affect anemia status).
- Patients with communication difficulties due to dementia or other factors (to ensure accurate symptom reporting and study adherence).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Levocarnitine Injections on Reducing Erythropoietin-Stimulating Agent Requirements in Hemodialysis Patients With Renal Anemia
Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Carnitine deficiency is frequent in hemodialysis because carnitine is lost during dialysis and its synthesis is reduced. Levocarnitine may improve red blood cell function and reduce the dose of ESA needed to maintain hemoglobin.
This single-center, randomized controlled trial will test whether adding intravenous levocarnitine to standard care reduces ESA requirements in adults on maintenance hemodialysis who have renal anemia. Ninety-four participants (age 20-60 years) on thrice-weekly hemodialysis for ≥6 months and with hemoglobin <10 g/dL will be randomly assigned (1:1) to:
Read more
Intervention: Levocarnitine 1,000 mg IV three times per week, administered after each dialysis session, plus usual anemia care including ESA per unit protocol.
Control: Usual anemia care including ESA per unit protocol without levocarnitine.
Participants will be followed for 6 months. Hemoglobin, hematocrit, ESA dose, and the erythropoietin responsiveness index (ERI = monthly ESA dose ÷ [dry weight × average hemoglobin]) will be recorded monthly.
The primary outcome is the ESA dose (units/week) at month 6. Secondary outcomes include ERI and monthly changes in hemoglobin and hematocrit, along with routine safety monitoring. If levocarnitine lowers ESA needs, the findings may offer a cost-effective strategy to optimize anemia management in hemodialysis patients.
Read the detailed description
Background and Rationale. Carnitine supports erythrocyte membrane stability and energy metabolism. In maintenance hemodialysis, endogenous carnitine synthesis is reduced and dialytic losses occur, potentially contributing to ESA hyporesponsiveness. Small trials suggest that levocarnitine may reduce ESA dose requirements while maintaining target hemoglobin. Robust, region-specific evidence is limited.
Study Overview. This is a single-center, two-arm, randomized (1:1), open-label, parallel-group trial conducted at the Department of Nephrology, Shaikh Zayed Hospital, Lahore. Adults on thrice-weekly maintenance hemodialysis are randomized to: (A) adjunct levocarnitine 1,000 mg IV after each dialysis session, or (B) standard care without levocarnitine. ESA therapy is provided to all participants according to institutional practice, with dose adjustments based on routine hemoglobin monitoring. Study follow-up is 6 months, with monthly assessments of laboratory indices and ESA use. Full eligibility criteria, outcome measures (including the definition of the erythropoietin responsiveness index), intervention details, and visit schedule are specified in the corresponding PRS modules.
Statistical Considerations. The trial is powered (80% at α=0.05) to detect a between-group difference in ESA use at 6 months based on prior data; the planned sample size is 94 participants (47 per group). Analyses will follow the intention-to-treat principle, with supportive per-protocol analyses. Continuous outcomes will be summarized as mean±SD or median [IQR], and compared using appropriate two-sample methods. Prespecified subgroup and sensitivity analyses may adjust for baseline factors such as age, sex, BMI, and comorbidity status.
Safety and Monitoring. Adverse events and intercurrent illnesses are captured at each visit and via clinical record review. Any clinically significant events will be reported per institutional procedures. Data will be recorded on standardized case-report forms and managed to protect participant confidentiality.
Significance. Demonstrating reduced ESA requirements with levocarnitine while maintaining target hemoglobin could improve patient care and lower treatment costs in resource-constrained dialysis programs.
- Conditions
- Anemia, Kidney Failure, End-Stage Renal Disease, Renal Dialysis
- Being tested
- Levocarnitine Injection, Usual ESA-Based Anemia Care
- Keywords
- Levocarnitine, L-carnitine, Erythropoiesis-Stimulating Agents, Erythropoietin Responsiveness Index, Hematocrit
- Medical subject headings
- Anemia, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocarnitine InjectionDrug
Also called L-carnitine, Levocarnitine, Carnitine
1,000 mg levocarnitine IV (slow IV push or infusion per unit policy) post-hemodialysis, three times weekly for 6 months (~72 doses). Administered in the dialysis unit in addition to usual ESA-based anemia care.
Usual ESA-Based Anemia CareOther
Standard-of-care anemia management using recombinant human erythropoietin (ESA) per unit protocol. Typical initial dosing: 50-100 U/kg/week if Hb <10 g/dL (in 2-3 doses/week); 50 U/kg/week if Hb 10-11 g/dL; 25-50 U/kg/week as maintenance if Hb 11-12 g/dL. ESA dose adjusted monthly using ERI and Hb/Hct targets (generally Hb 10-12 g/dL).
| Study group | Role | What they receive |
|---|---|---|
| Levocarnitine + Usual ESA Care | Experimental | Adults on maintenance hemodialysis with renal anemia receive levocarnitine 1,000 mg IV immediately after each dialysis session, three times per week for 6 months, in addition to standard anemia management with erythropoiesis-stimulating agents (ESA) per unit protocol. Monthly assessments of hemoglobin, hematocrit, ESA dose, and erythropoietin responsiveness index (ERI). Receives: Drug: Levocarnitine Injection; Other: Usual ESA-Based Anemia Care |
| Usual ESA Care (No Levocarnitine) | Active comparator | Standard anemia management with ESA per unit protocol without levocarnitine. Monthly assessments of hemoglobin, hematocrit, ESA dose, and ERI over 6 months. Receives: Other: Usual ESA-Based Anemia Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly ESA dose at Month 6 (units/week)
Total weekly dose of erythropoiesis-stimulating agent (ESA; recombinant human erythropoietin or biosimilar) abstracted from the dialysis unit medication administration record. Recorded as the sum of ESA units administered in the 7-day period closest to the Month-6 visit. Lower values indicate an ESA-sparing effect.
Measured: Month 6 (plus or minus 2 weeks) after randomization
Secondary outcomes (1)
Change in weekly ESA dose from Baseline to Month 6 (units/week)
Difference = (Month-6 weekly ESA dose) - (Baseline weekly ESA dose), from medication records. Negative values indicate dose reduction.
Measured: Baseline and Month 6 (±2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, two-arm, open-label, randomized controlled trial with 1:1 allocation by simple randomization (lottery). Adults on maintenance hemodialysis with renal anemia are assigned to levocarnitine 1,000 mg IV three times weekly after dialysis plus usual ESA care versus usual ESA care without levocarnitine. Follow-up 6 months; monthly assessments of Hb, Hct, ESA dose, and ERI.
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaikh Zayed Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzla Arshad, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160452
- Sponsor's protocol ID
- TERC/SC/INT/2025/455
- Acronym
- L-CAR-ESA
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results will be available to qualified researchers upon reasonable request after publication of the primary manuscript.
Publications
Morgans HA, Chadha V, Warady BA. The role of carnitine in maintenance dialysis therapy. Pediatr Nephrol. 2021 Aug;36(8):2545-2551. doi: 10.1007/s00467-021-05101-z. Epub 2021 Jun 18.
PubMed 34143302Kadiroglu AK, Yilmaz ME, Sit D, Kara IH, Isikoglu B. The evaluation of postdialysis L-carnitine administration and its effect on weekly requiring doses of rHuEPO in hemodialysis patients. Ren Fail. 2005;27(4):367-72.
PubMed 16060121Maruyama T, Higuchi T, Yamazaki T, Okawa E, Ando H, Oikawa O, Inoshita A, Okada K, Abe M. Levocarnitine Injections Decrease the Need for Erythropoiesis-Stimulating Agents in Hemodialysis Patients with Renal Anemia. Cardiorenal Med. 2017 Jun;7(3):188-197. doi: 10.1159/000462983. Epub 2017 Apr 20.
PubMed 28736559
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Levocarnitine Injections on Reducing Erythropoietin-Stimulating Agent Requirements in Hemodialysis Patients With Renal Anemia
- ClinicalTrials.gov ID
- NCT07160452
- Acronym / sponsor ID
- L-CAR-ESA / TERC/SC/INT/2025/455
- Conditions
- Anemia, Kidney Failure, End-Stage Renal Disease, Renal Dialysis
- Keywords
- Levocarnitine, L-carnitine, Erythropoiesis-Stimulating Agents, Erythropoietin Responsiveness Index, Hematocrit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Shaikh Zayed Hospital, LahoreUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 8 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.
Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Carnitine deficiency is frequent in hemodialysis because carnitine is lost during dialysis and its synthesis is reduced. Levocarnitine may improve red blood cell function and reduce the dose of ESA needed to maintain hemoglobin.
This single-center, randomized controlled trial will test whether adding intravenous levocarnitine to standard care reduces ESA requirements in adults on maintenance hemodialysis who have renal anemia. Ninety-four participants (age 20-60 years) on thrice-weekly hemodialysis for ≥6 months and with hemoglobin <10 g/dL will be randomly assigned (1:1) to:
Intervention: Levocarnitine 1,000 mg IV three times per week, administered after each dialysis session, plus usual anemia care including ESA per unit protocol.
Control: Usual anemia care including ESA per unit protocol without levocarnitine.
Participants will be followed for 6 months. Hemoglobin, hematocrit, ESA dose, and the erythropoietin responsiveness index (ERI = monthly ESA dose ÷ [dry weight × average hemoglobin]) will be recorded monthly.
The primary outcome is the ESA dose (units/week) at month 6. Secondary outcomes include ERI and monthly changes in hemoglobin and hematocrit, along with routine safety monitoring. If levocarnitine lowers ESA needs, the findings may offer a cost-effective strategy to optimize anemia management in hemodialysis patients.
Detailed description
Background and Rationale. Carnitine supports erythrocyte membrane stability and energy metabolism. In maintenance hemodialysis, endogenous carnitine synthesis is reduced and dialytic losses occur, potentially contributing to ESA hyporesponsiveness. Small trials suggest that levocarnitine may reduce ESA dose requirements while maintaining target hemoglobin. Robust, region-specific evidence is limited.
Study Overview. This is a single-center, two-arm, randomized (1:1), open-label, parallel-group trial conducted at the Department of Nephrology, Shaikh Zayed Hospital, Lahore. Adults on thrice-weekly maintenance hemodialysis are randomized to: (A) adjunct levocarnitine 1,000 mg IV after each dialysis session, or (B) standard care without levocarnitine. ESA therapy is provided to all participants according to institutional practice, with dose adjustments based on routine hemoglobin monitoring. Study follow-up is 6 months, with monthly assessments of laboratory indices and ESA use. Full eligibility criteria, outcome measures (including the definition of the erythropoietin responsiveness index), intervention details, and visit schedule are specified in the corresponding PRS modules.
Statistical Considerations. The trial is powered (80% at α=0.05) to detect a between-group difference in ESA use at 6 months based on prior data; the planned sample size is 94 participants (47 per group). Analyses will follow the intention-to-treat principle, with supportive per-protocol analyses. Continuous outcomes will be summarized as mean±SD or median [IQR], and compared using appropriate two-sample methods. Prespecified subgroup and sensitivity analyses may adjust for baseline factors such as age, sex, BMI, and comorbidity status.
Safety and Monitoring. Adverse events and intercurrent illnesses are captured at each visit and via clinical record review. Any clinically significant events will be reported per institutional procedures. Data will be recorded on standardized case-report forms and managed to protect participant confidentiality.
Significance. Demonstrating reduced ESA requirements with levocarnitine while maintaining target hemoglobin could improve patient care and lower treatment costs in resource-constrained dialysis programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, two-arm, open-label, randomized controlled trial with 1:1 allocation by simple randomization (lottery). Adults on maintenance hemodialysis with renal anemia are assigned to levocarnitine 1,000 mg IV three times weekly after dialysis plus usual ESA care versus usual ESA care without levocarnitine. Follow-up 6 months; monthly assessments of Hb, Hct, ESA dose, and ERI.
| Arm | Type | Receives |
|---|---|---|
| Levocarnitine + Usual ESA Care | Experimental | Drug: Levocarnitine Injection, Other: Usual ESA-Based Anemia CareAdults on maintenance hemodialysis with renal anemia receive levocarnitine 1,000 mg IV immediately after each dialysis session, three times per week for 6 months, in addition to standard anemia management with erythropoiesis-stimulating agents (ESA) per unit protocol. Monthly assessments of hemoglobin, hematocrit, ESA dose, and erythropoietin responsiveness index (ERI). |
| Usual ESA Care (No Levocarnitine) | Active comparator | Other: Usual ESA-Based Anemia CareStandard anemia management with ESA per unit protocol without levocarnitine. Monthly assessments of hemoglobin, hematocrit, ESA dose, and ERI over 6 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both male and female patients
- Patients aged 20-60 years.
- Patients undergoing maintenance hemodialysis three times a week for at least six months
- Patients having renal anemia
Key exclusion criteria (6 listed)
- Patients currently using any carnitine preparation as a supplement (to avoid confounding effects from additional carnitine intake).
- Patients on immunosuppressive drugs, steroids, or antibiotics (to avoid the influence of these medications on anemia and carnitine metabolism).
- Patients who have previously received levocarnitine in either oral or injected form (to eliminate any prior influence of levocarnitine on study outcomes).
- Patients with a history of blood transfusion within the past 6 months (to exclude the immediate impact of transfusions on hemoglobin levels and anemia management).
- Patients with acute inflammation (to prevent interference with study parameters as inflammation can affect anemia status).
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 |
|---|---|---|
| Levocarnitine InjectionAlso: L-carnitine, Levocarnitine, Carnitine1,000 mg levocarnitine IV (slow IV push or infusion per unit policy) post-hemodialysis, three times weekly for 6 months (~72 doses). Administered in the dialysis unit in addition to usual ESA-based anemia care. | Drug | Levocarnitine + Usual ESA Care |
| Usual ESA-Based Anemia CareStandard-of-care anemia management using recombinant human erythropoietin (ESA) per unit protocol. Typical initial dosing: 50-100 U/kg/week if Hb <10 g/dL (in 2-3 doses/week); 50 U/kg/week if Hb 10-11 g/dL; 25-50 U/kg/week as maintenance if Hb 11-12 g/dL. ESA dose adjusted monthly using ERI and Hb/Hct targets (generally Hb 10-12 g/dL). | Other | Levocarnitine + Usual ESA Care, Usual ESA Care (No Levocarnitine) |
Primary outcome
Weekly ESA dose at Month 6 (units/week)
Time frame: Month 6 (plus or minus 2 weeks) after randomization
Total weekly dose of erythropoiesis-stimulating agent (ESA; recombinant human erythropoietin or biosimilar) abstracted from the dialysis unit medication administration record. Recorded as the sum of ESA units administered in the 7-day period closest to the Month-6 visit. Lower values indicate an ESA-sparing effect.
1 secondary outcome
Change in weekly ESA dose from Baseline to Month 6 (units/week)
Time frame: Baseline and Month 6 (±2 weeks)
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 12 Sep 2025.
- Background: PubMed 34143302Morgans HA, Chadha V, Warady BA. The role of carnitine in maintenance dialysis therapy. Pediatr Nephrol. 2021 Aug;36(8):2545-2551. doi: 10.1007/s00467-021-05101-z. Epub 2021 Jun 18.
- Background: PubMed 16060121Kadiroglu AK, Yilmaz ME, Sit D, Kara IH, Isikoglu B. The evaluation of postdialysis L-carnitine administration and its effect on weekly requiring doses of rHuEPO in hemodialysis patients. Ren Fail. 2005;27(4):367-72.
- Background: PubMed 28736559Maruyama T, Higuchi T, Yamazaki T, Okawa E, Ando H, Oikawa O, Inoshita A, Okada K, Abe M. Levocarnitine Injections Decrease the Need for Erythropoiesis-Stimulating Agents in Hemodialysis Patients with Renal Anemia. Cardiorenal Med. 2017 Jun;7(3):188-197. doi: 10.1159/000462983. Epub 2017 Apr 20.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results will be available to qualified researchers upon reasonable request after publication of the primary manuscript.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocarnitine Injection and Usual ESA-Based Anemia Care in people with Anemia and Kidney Failure, run by Shaikh Zayed Hospital, Lahore.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hanzla Doctor, M.Phil Pharmacy (00923131614162, hanzlaarshadbutt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly ESA dose at Month 6 (units/week) (time frame: Month 6 (plus or minus 2 weeks) after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07160452, which also lists 3 linked publications.
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 12 Sep 2025.