Abstract: TH-PO914
Hemoglobin Rate of Rise during Initial Treatment 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 Disease, Beijing, Beijing, China
- Huang, Cuihua, Medical Affairs, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
- Xia, Xiaoyan, 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 Disease, 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 Disease, Beijing, Beijing, China
Background
Clinical guidelines recommend a rate of rise (RoR) in hemoglobin (Hb) for chronic kidney disease (CKD) patients with anemia of 10-20 g/L/month, not exceeding 20 g/L/month during correction phase. We conducted a secondary analysis of a randomized study (ChiCTR2100045359) to evaluate RoR in Hb during the initial 8 weeks’treatment in non-dialysis CKD patients with anemia receiving a weight-based standard (<60/≥60 kg: 70/100 mg three times per week [TIW]) or lower (<60/≥60 kg: 50/70 mg TIW) starting dose of roxadustat.
Methods
This secondary analysis used existing data of a previous randomized study (primary results presented at ASN 2023 TH-PO1157). Patients treated with roxadustat who had at least one post-baseline Hb value were included. RoRs in Hb every 4 weeks and its distribution (ideal: 2.5-5 g/L/week; high: >5 g/L/week) during initial treatment (weeks 0–8) were evaluated.
Results
A total of 249 patients (126 in lower starting-dose and 123 in standard starting-dose arms) were included. Overall baseline Hb was 89.9±6.9 g/L. Patients in the lower-dose arm experienced slower ROR (g/L/week) in Hb during weeks 0–4 (3.3 [3.0] vs. 4.7 [3.2], P=0.0003) and weeks 0–8 (2.6 [1.9] vs. 3.3 [1.7], P=0.0024) compared to the standard-dose arm (Table). In the lower-dose arm, there were fewer patients with Hb RoR >5 g/L/week (4.8% [6/124] vs. 11.6% [14/121], P=0.0278), more patients with Hb RoR <2.5 g/L/week (45.2% [56/124] vs. 28.1% [34/121], P=0.0029), and a similar patients with Hb RoR 2.5–5 g/L/week during weeks 0-8 (50.0% [62/124] vs. 60.3% [73/121], P=0.0996) compared to the standard-dose group.
Conclusion
Both lower and standard starting doses of roxadustat corrected anemia with an ideal RoR in Hb for non-dialysis CKD patients during initial treatment. Patients receiving the lower starting dose had a slower RoR and fewer patients with high RoR.
Rate of rise in Hb during initial treatment
| Statistic | Overall | CKD Stage 3-4 | CKD Stage 5 | |||
| Lower (n=126) | Standard (n=123) | Lower (n=77) | Standard (n=72) | Lower (n=49) | Standard (n=51) | |
| Weeks 0-4, Mean (SD) | 3.3 (3.0) | 4.7 (3.2) | 3.5 (3.0) | 5.3 (3.1) | 2.9 (2.9) | 3.9 (3.1) |
| Difference, 95% CI | -1.4 (-2.2, -0.7) | -1.9 (-2.9, -0.8) | -0.9 (-2.2, 0.3) | |||
| Weeks 4-8, Mean (SD) | 2.1 (2.7) | 1.6 (3.4) | 2.1 (2.7) | 1.0 (3.5) | 2.0 (2.8) | 2.6 (3.1) |
| Difference, 95% CI | 0.4 (-0.4, 1.2) | 1.0 (-0.0, 2.1) | -0.5 (-1.7, 0.7) | |||
| Weeks 0-8, Mean (SD) | 2.6 (1.9) | 3.3 (1.7) | 2.8 (1.8) | 3.3 (1.8) | 2.3 (2.1) | 3.2 (1.7) |
| Difference, 95% CI | -0.7 (-1.2, -0.3) | -0.6 (-1.2, -0.1) | -0.8 (-1.6, -0.1) | |||
| CI, confidence interval; CKD, chronic kidney disease; Hb, hemoglobin; SD, standard deviation. Rate of Rise is defined as a slope from a linear regression model estimated using Hb values in the given time period. Treatment comparisons were performed using Analysis of Covariance, taking baseline Hb and baseline estimate glomerular filtration rate as covariates. | ||||||
Funding
- Commercial Support – FibroGen (China) sponsored this study