To observe the clinical efficacy of roxadustat capsules combined with levocarnitine injection in patients with renal failure undergoing combined hemoperfusion (HP) and hemodialysis (HD).

Patients with chronic renal failure were randomly divided into control group and treatment group using a random number table method. The control group was treated with HP+HD combined with intravenous levocarnitine (1.0 g per session, 3 times per week). On the basis of control group, treatment group received additional oral roxadustat capsules. The starting dose was selected according to the patient’s body weight: 100 mg per dose (45-60 kg) or 120 mg per dose (≥60 kg), 3 times per week, with dose adjustments made every 4 weeks. The total course of treatment was 12 weeks. The renal function parameters, nutritional status indicators, iron metabolism-related indices, medical research council (MRC) scores and clinical efficacy were compared between the two groups, and the safety was assessed.

A total of 165 patients who met the preliminary screening criteria were screened for this study. According to the inclusion and exclusion criteria, 17 ineligible patients were excluded, resulting in 148 patients being ultimately enrolled. These participants were randomly assigned to either the treatment group or the control group, with 74 patients in each. No dropouts occurred in either group during the trial. After treatment, the levels of serum creatinine (Scr) in the control group and the treatment group were (338.46±35.69) and (321.94±49.87) mL·min^-1, respectively; the albumin (ALB) levels were (35.74±5.32) and (38.12±6.07) g·L^-1, respectively; the hemoglobin (HB) levels were (112.26±11.79) and (118.17±8.16) g·L^-1, respectively; the HB compliance rates were 60.81% and 82.43%, respectively; the serum iron (SI) levels were (13.85±2.87) and (15.34±2.93) μmol·L^-1, respectively; the serum ferritin (SF) levels were (328.87±54.36) and (351.87±42.74) ng·mL^-1, respectively; the transferrin saturation (TSAT) levels were (28.97±6.29)% and (32.17±6.75)%, respectively; and the MRC total scores were (49.20±8.77) and (53.26±6.91) points, respectively. The treatment group demonstrated statistically significantly greater improvement in the aforementioned indices compared to control group (P<0.05, P<0.01). The main adverse drug reactions of treatment group were nausea and vomiting, elevated blood pressure, muscle spasm and diarrhea; the control group had nausea and vomiting, elevated blood pressure, headache, muscle spasm and diarrhea. The total incidence of adverse drug reactions in treatment group and control group were 9.46% and 12.16%, respectively, with no statistically significant difference (P>0.05).

The combination of roxadustat capsules and levocarnitine injection effectively reduces renal impairment, improves nutritional and iron status, alleviates muscle weakness, and is well-tolerated in chronic renal failure patients undergoing combined HP+HD therapy.