Victoria Socha

DocwireNews

&nbsp;&nbsp;&nbsp;Patients in China with chronic kidney disease-associated anemia (CKD-anemia) with and without dialysis are commonly treated with roxadustat. Ping Li and colleagues conducted a trial to determine the noninferiority of lower starting dose (LSD) of roxadustat versus standard starting dose (SSD) for the treatment of stage 3-5 CKD-anemia in patients not receiving dialysis.Results of the trial were reported during a poster session at the American Society of Nephrology Kidney Week 2023. The poster was titled A Randomized, Controlled, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Lower Starting Dose Roxadustat for Anemia Treatment in Patients With CKD Not on Dialysis.Patients were randomized 1:1 to a weight-based SSD (&lt;60 kg, 70 mg three times per week; &ge;60 kg, 100 mg three times per week) or LSD (&lt;60 kg, 50 mg three times per week; &ge;60 kg, 70 mg three times per week). Treatment continued for 16 weeks, with assessments every two weeks for 8 weeks, then every 4 weeks.The primary efficacy end point of interest was the mean change in hemoglobin from baseline over weeks 12 to 16. Adverse events were assessed throughout the study period and 4 weeks following study completion.A total of 254 patients were randomized to SSD (n=128) or LSD (n=126). The two groups were similar in baseline characteristics. At baseline, hemoglobin was 89.4 g/L in the LSD group and 90.6 g/L in the SSD group.In the per protocol set (n=226), the mean change in hemoglobin from baseline over 12 to 16 weeks in the LSD group was 21.6 g/L compared with 26.4 g/L in the SSD group (95% CI, &ndash;7.77 to &ndash;1.79 g/L [&lt;&ndash;5 g/L noninferiority margin]). In the per-protocol-set, 47.8% of patients in the LSD group achieved hemoglobin 100 to 120 g/L over weeks 12 to 16, compared with 47.7% in the SSD group (odds ratio, 1.158; 95% CI, 0.671-1.996; P=.60). Results of the full analysis set (n=249) were similar. The rates of change in hemoglobin from baseline in the LSD group were significantly lower from baseline to weeks 4 (P=.03), 8 (P=.03), and 16 (P&lt;.01).Overall, five patients received rescue therapy: three in the LSD group (2.4%) and two in the SSD group (1.6%). In the safety set (n=250), 68.0% of participants had treatment-emergent adverse events (72.2% in the LSD group and 63.7% in the SSD group). The proportions of treatment-emergent serious adverse events and drug related adverse events were numerically higher in the LSD group than in the SSD group (24.6% vs 10.5% and 4.0% vs 2.4%, respectively).In conclusion, the authors said, &ldquo;Noninferiority was not established for the LSD compared with the SSD in stage 3-5 CKD nondialysis patients. The proportion of patients who achieved hemoglobin 100-120 g/L over weeks 12-16 for both groups was similar; patients receiving the LSD had less hemoglobin fluctuation. Both dosages were well tolerated, however, LSD did not show a better safety profile.Source: Li P, Cai G, Sun X, et al. A randomized, controlled, open-label, multicenter study evaluating the efficacy and safety of lower starting dose roxadustat for anemia treatment in patients with CKD not on dialysis. <a href="https://www.asn-online.org/education/kidneyweek/2023/program-abstract.aspx?controlId=3978782" target="_blank" rel="noopener">TH-PO1157</a>. Abstract of a poster presented at the American Society of Nephrology Kidney Week 2023; November 2, 2023; Philadelphia, Pennsylvania.

Bradley Marder, MD

Joel M. Topf, MD, FACP

Gout Studies: Transplant Waitlisting and Bone Erosion

NKF Spring Clinical Meetings 2025

Jayme Locke, MD, MPH

The Promise of Xenotransplantation

Leah Lawrence

Real-World Data Backs Invasive DFS as Surrogate Endpoint for OS in EBC

HR Breast Cancer

Latest News

Efficacy, Safety of Lower Starting Dose of Roxadustat for CKD-Associated Anemia

Anemia and Kidney Disease

Assessing the noninferiority of lower starting dose of roxadustat versus standard starting dose for the treatment of stage 3-5 CKD-anemia.

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HER2 Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe