This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
201
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Tokyo, Japan
The percent changes in intact Parathyroid hormone levels from baseline
Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
Time frame: Up to 3 weeks
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.
Time frame: Up to 3 weeks
Safety
1. Number and types of adverse events 2. laboratory tests 3. vital signs 4. 12-lead electrocardiogram 5. ophthalmological examination
Time frame: Up to 3 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oral administration
Oral administration