Effect of Levocarnitine Injections on Reducing Erythropoietin-Stimulating Agent Requirements in Hemodialysis Patients With Renal Anemia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 主要终点
- Weekly ESA dose at Month 6 (units/week)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label; no parties masked. Primary outcomes (ESA dose, ERI, Hb/Hct) are obtained from routine records.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Levocarnitine + Usual ESA Care
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).
干预措施: Levocarnitine Injection (Drug)
Levocarnitine + Usual ESA Care
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).
干预措施: Usual ESA-Based Anemia Care (Other)
Usual ESA Care (No Levocarnitine)
Standard anemia management with ESA per unit protocol without levocarnitine. Monthly assessments of hemoglobin, hematocrit, ESA dose, and ERI over 6 months.
干预措施: Usual ESA-Based Anemia Care (Other)
结局指标
主要结局
Weekly ESA dose at Month 6 (units/week)
时间窗: 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.
次要结局
- Change in weekly ESA dose from Baseline to Month 6 (units/week)(Baseline and Month 6 (±2 weeks))
研究者
Hanzla Arshad
Doctor
Shaikh Zayed Hospital, Lahore