This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Meiyo Clinic
Toyohashi, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
Japanese Red Cross Koga Hospital
Koga, Ibaragi, Japan
Sumiyoshi Clinic Hospital
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
Change in serum inorganic phosphorus at the end of treatment from baseline
Time frame: baseline and end of the chewing treatment during three week treatment period
Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL
Time frame: baseline and end of the treatment
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3
Time frame: week 3
Serum Inorganic Phosphorus Level
Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time frame: week 3
Salivary Inorganic Phosphorus Level
Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time frame: week 3
Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])
Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time frame: week 3
Ca×P
Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time frame: week 3
Serum Intact Parathyroid Hormone (PTH) Level
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mito, Ibaragi, Japan
Toride Medical Center
Toride, Ibaragi, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaragi, Japan
Japanese Red Cross Suwa Hospital
Suda, Nagano, Japan
Maruko General Hospital
Ueda, Nagano, Japan
Komagome Kyouritsu Clinic
Tokyo, Tokyo, Japan
Asagaya Suzuki Clinic
Tokyo, Tokyo, Japan
...and 1 more locations
Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time frame: week 3
Serum Intact Fibroblast Growth Factor (FGF) 23 Level
Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time frame: week 3