Abstract: TH-PO1188
Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia
Session Information
- Late-Breaking Science Posters
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Block, Geoffrey A., US Renal Care Inc, San Antonio, Texas, United States
- Chertow, Glenn M., Stanford University School of Medicine, Stanford, California, United States
- Reddy, Guru, Unicycive Therapeutics, Inc., Los Altos, California, United States
- Mourya, Sanjay S., Unicycive Therapeutics, Inc., Los Altos, California, United States
- Block, Martha, US Renal Care Inc, San Antonio, Texas, United States
- Hasal, Steve, Unicycive Therapeutics, Inc., Los Altos, California, United States
- Gupta, Shalabh, Unicycive Therapeutics, Inc., Los Altos, California, United States
- Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
Background
In patients with chronic kidney disease (CKD) on dialysis, hyperphosphatemia is managed by reducing dietary intake of phosphate (P) and phosphate lowering therapies. Oxylanthanum carbonate (OLC) is a phosphate binder in development with high potency and low pill burden. This study assessed the general tolerability of OLC in hyperphosphatemic CKD patients on hemodialysis.
Methods
We conducted a Phase 2, open-label, single-arm, multicenter, multidose study in adult patients with hyperphosphatemia receiving maintenance hemodialysis. The primary objective was to evaluate the tolerability of OLC at clinically effective doses (goal serum P ≤5.5 mg/dL). The study included Washout, Titration, and Maintenance Periods. Eligible patients had serum P ≥4.0 mg/dL and ≤7.5 mg/dL for at least 8 weeks prior to screening while on stable hemodialysis and P-lowering regimens. Patients started titration when their serum P was >5.5 mg/dL and entered maintenance once their serum P was ≤5.5 mg/dL, or after 6 weeks, whichever was sooner. The starting dose of OLC during titration was 1500 mg/day (500 mg TID). We assessed tolerability based on the incidence of discontinuations due to adverse drug reactions (ADRs).
Results
A total of 86 patients were treated with OLC during the study. At screening, serum P was ≤5.5 mg/dL in 51 (59%) patients on a stable P-binder regimen. A total of 78 patients entered maintenance, and 71 (91%) patients had serum P <5.5 mg/dL on a median dose of 1500 mg/day. The most common ADRs were gastrointestinal and included diarrhea (9%) and vomiting (6%); all other ADRs were reported in <5% of patients. Two patients discontinued due to ADRs during titration and 1 patient during maintenance.
Conclusion
In this open-label study, use of OLC enabled adequate control of serum P in >90% of patients who entered maintenance. OLC was safe and generally well-tolerated with ADRs commonly seen in this patient population and with other P binders.
Patients with Treatment-Emergent Adverse Events (TEAEs)
| TEAEs (N=86) n (%) | ADRs (N=86) n (%) | |
| Serious AEs | 5 (6) | 0 |
| AEs Leading to Discontinuation | 5 (6) | 3 (4) |
| Common AEs | ||
| Diarrhea | 10 (12) | 8 (9) |
| Vomiting | 5 (6) | 5 (6) |
Funding
- Commercial Support – Unicycive Therapeutics, Inc.