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NaPi-IIb Inhibition for Hyperphosphatemia in CKD Hemodialysis Patients
Sonomi Maruyama1, Thomas C Marbury2, Jeffrey Connaire3
1Daiichi Sankyo, Inc., Basking Ridge, New Jersey, USA.
Kidney International Reports
|March 18, 2021
Summary
This study found that DS-2330b, a phosphate absorption inhibitor, was safe for patients with chronic kidney disease on hemodialysis but did not significantly lower serum phosphate levels.
Area of Science:
- Nephrology
- Pharmacology
Background:
- Chronic kidney disease (CKD) affects 9.1% of the global population.
- Elevated serum phosphate in hemodialysis (HD) patients increases cardiovascular risks.
- DS-2330b is an oral NaPi-IIb inhibitor investigated for phosphate reduction.
Purpose of the Study:
- To evaluate the safety and efficacy of DS-2330b in patients with CKD undergoing HD.
- To assess DS-2330b's effect on serum phosphate levels.
- To compare DS-2330b formulations and its combination with sevelamer.
Main Methods:
- Phase 1b, randomized, placebo-controlled study in 2 parts.
- Part A: Assessed safety and pharmacokinetics of DS-2330b formulations.
- Part B: Evaluated safety and serum phosphate reduction with DS-2330b (400 mg TID) alone or with sevelamer for 14 days.
Main Results:
- DS-2330b was safe and well-tolerated in HD patients.
- Serum phosphate mean change from baseline was -2.2±1.5 mg/dl for DS-2330b monotherapy versus -1.9 ± 1.1 mg/dl for placebo.
- Combined DS-2330b and sevelamer showed the greatest phosphate decrease, but efficacy was not clinically meaningful.
Conclusions:
- DS-2330b demonstrated a favorable safety profile in CKD patients on HD.
- The drug did not achieve clinically significant reductions in serum phosphate levels.
- Further research may be needed to explore alternative therapeutic strategies for hyperphosphatemia in CKD.
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