Abstract: TH-PO915
Hemoglobin Variability in Nondialysis-Dependent Patients with CKD and Anemia: Secondary Analysis of a Randomized Controlled Study
Session Information
- Anemia and Iron Metabolism
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Li, Ping, Department of Nephrology, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People’s Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, Beijing, China
- Huang, Cuihua, Medical Affairs, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
- Tang, Shirui, Medical Affairs, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
- Pan, Shuting, Clinical Biometrics, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
- Cai, Guangyan, Department of Nephrology, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People’s Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, Beijing, China
- Chen, Xiangmei, Department of Nephrology, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People’s Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, Beijing, China
Background
In a previous randomized study, a smaller absolute value of the rate of hemoglobin (Hb) change was seen during 16-weeks’ treatment for non-dialysis patients with chronic kidney disease (CKD) and anemia receiving a lower roxadustat starting dose (<60/≥60 kg: 50/70 mg three times per week [TIW]) compared to the standard starting dose (<60/≥60 kg: 70/100 mg TIW), indicating less temporal Hb variability with a lower starting dose of roxadustat (previously published, ASN 2023 TH-PO1157). We conducted a secondary analysis of this study to evaluate Hb variability in both arms by non-temporal methods.
Methods
This was a secondary analysis of study ChiCTR2100045359. Patients treated with roxadustat and with at least one non-missing post-baseline Hb value were included. Hb variability was measured throughout the entire treatment period (16 weeks) by typical non-temporal methods: standard deviation (SD), coefficient variation (CV), and residual SD of Hb. The proportion of patients who achieved Hb treatment targets of 110–130 and 100–130 g/L averaged over weeks 12-16 was counted.
Results
A total of 249 patients were included (126 in lower starting-dose and 123 in standard starting-dose arms). Overall baseline Hb was 89.9±6.9 g/L. More patients in the standard-dose arm achieved the Hb treatment targets of 110–130 g/L (lower, 50.8% [64/126]; standard, 68.3% [84/123]; odds ratio [OR] [95%CI]: 0.54 [0.31, 0.94], P=0.0293), and 100–130 g/L (lower, 69.8% [88/126]; standard, 86.2% [106/123]; OR [95%CI]: 0.42 [0.20, 0.88], P=0.0217) averaged over weeks 12–16. Patients in the lower-dose arm had significantly less SD of Hb (lower, 11.1 [4.2] g/L; standard, 12.4 [4.1] g/L; difference [95%CI]: -1.4 [-2.4, -0.4] g/L, P=0.0078), and less residual SD of Hb (lower, 7.9 [4.0] g/L; standard, 9.1 [4.1] g/L; difference [95%CI]: -1.2 [-2.3, -0.2] g/L, P=0.0195). The CV of Hb was also less for the lower-dose arm, but the difference was not significant (lower, 10.8% [4.0%]; standard 11.4% [3.7%]; difference [95%CI]: -0.8% [-1.7%, 0.1%], P=0.0651).
Conclusion
More patients treated with the standard starting dose of roxadustat achieved Hb treatment targets at weeks 12–16. However, Hb variability during the 16-week treatment period was less for patients receiving the lower starting dose.
Funding
- Commercial Support – FibroGen (China) sponsored this study