©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
Sucroferric oxyhydroxide monotherapy for hyperphosphatemia in Indian chronic kidney disease patients undergoing hemodialysis: A phase IV, single-arm, open-label study
M R Niranjan, Sanjay Srinivasa, Vibhanshu Gupta, Anil K Bhalla, Ankush Gaikwad, Prajakta Wangikar, Sachin Suryawanshi, Priti Gajbe
M R Niranjan, Department of Nephrology, Mysore Medical College and Research Institute, Mysore 570001, Karnātaka, India
Sanjay Srinivasa, Department of Nephrology, Dr. Sanjay’s Center for Kidney and Diabetes, Bengaluru 560064, Karnātaka, India
Vibhanshu Gupta, Department of Nephrology, Pushpanjali Hospital and Research Centre, Agra 282002, Uttar Pradesh, India
Anil K Bhalla, Department of Nephrology, Sir Ganga Ram Hospital, New Delhi 110060, Delhi, India
Ankush Gaikwad, Prajakta Wangikar, Sachin Suryawanshi, Priti Gajbe, Department of Medical Services, Emcure Pharmaceuticals Ltd, Mumbai 400072, Mahārāshtra, India
Co-corresponding authors: Sanjay Srinivasa and Sachin Suryawanshi.
Author contributions: Niranjan MR, Gupta V, Srinivasa S and Bhalla AK contributed to the execution of the research, data analysis, statistical analysis, manuscript preparation and manuscript editing and review; Gaikwad A was involved in the conceptualization and study design, manuscript preparation, and manuscript editing and review; Wangikar P, Suryawanshi S and Gajbe P contributed to manuscript preparation, and manuscript editing and review; all of the authors read and approved the final version of the manuscript to be published.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee, Institutional Ethics Committee, ECR/1512/Inst/KA/2021; Institutional Ethics Committee, Mysore Medical College and Research Institute and Associate Hospital, ECR/134/Inst/KA/2013/RR-19; Pushpanjali Hospital Ethics ECR/1235/Lnst/UP/2019; and Ethics Committee Sir Ganga Ram Hospital, ECR/20/Inst/DL/2013/RR-19.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Gaikwad A, Wangikar P, Suryawanshi S and Gajbe P are employees of Emcure Pharmaceuticals, India.
CONSORT 2010 statement: We did not use CONSORT (for reporting a randomised trial).
Data sharing statement: No additional data are available.
Corresponding author: Sanjay Srinivasa, DNB, MD, Doctor, Department of Nephrology, Dr. Sanjay’s Center for Kidney and Diabetes, 357/B, Bangalore Bellary Road, Near to HDFC Bank, Yelahanka Town, Opposite RR Gold Palace, Bengaluru 560064, Karnātaka, India.
drsanjay.nephro@gmail.com
Received: August 8, 2024
Revised: December 2, 2024
Accepted: February 6, 2025
Published online: June 25, 2025
Processing time: 244 Days and 1.5 Hours
BACKGROUND
Hyperphosphatemia (HP) is a common complication in an advanced stage of chronic kidney disease (CKD) and is associated with cardiovascular issues, metabolic bone abnormalities and worsening of secondary hyperparathyroidism. Most patients on dialysis require phosphate binders to control HP. Sucroferric oxyhydroxide (SO) (Dynulta™) is a calcium-free, polynuclear iron (III) based oral phosphate binder, for the treatment of HP. In this phase IV, open-label, single-arm, multi-center, 12-week, SOLO CKD study evaluated efficacy and safety of Dynulta™ in Indian CKD patients undergoing hemodialysis.
AIM
To investigate the efficacy, safety and tolerability of SO Chewable Tablet (Dynulta™) in patients with CKD on hemodialysis.
METHODS
Hyperphosphatemic patients on hemodialysis and fulfilling eligibility criteria were included in the study for at least 12 weeks and received SO 1500 mg chewable tablet per day. The key endpoint was change in mean serum phosphorus levels after 12 weeks. Data were analysed using analysis of variance, Paired test, Wilcoxon test, and post-hoc comparisons, with P < 0.05 considered statistically significant, using Graph Pad software.
RESULTS
A total of 114 patients were enrolled and 94 patients completed the study. The mean ± SD serum phosphorous level was reduced from 7.62 mg/dL ± 2.02 mg/dL at baseline to 5.13 mg/dL ± 1.88 mg/dL after 12 weeks of treatment. At each follow-up visit, the reduction in mean serum phosphorous levels was statistically significant (P value < 0.05) compared to baseline, confirming the efficacy of SO. A total of 33.33% of patients experienced adverse events (AEs). The most frequently reported AEs were pyrexia, nasopharyngitis and headache, which were considered unlikely to be related to the study drug treatment. No serious AEs was reported during the study period and no patients discontinued treatment due to AEs.
CONCLUSION
This first real-world study in Indian CKD patients on hemodialysis shows SO as a safe, and effective monotherapy for HP, though its small sample size limits generalizability.
Core Tip: This is the first research study on the use of Sucroferric oxyhydroxide (SO) in Indian patients and also marks the first such study from the Southeast Asia region. The study was a single-arm study, registered with the Clinical Trials Registry India. The positive results from this study will add to the growing body of evidence, primarily generated in the United States and European Union, supporting the efficacy of SO in the Asian population.
