A Phase 2 interventional study of Dose-adjusted SK-1403 in Secondary Hyperparathyroidism, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 2, Interventional, and Treatment
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's enrollment of 58 is close to the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →Sanwa Kagaku Kenkyusho Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dose-adjusted SK-1403
SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Assessed by laboratory test value
Time frame: 18 weeks
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Assessed by laboratory test value
Time frame: 18 weeks
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Assessed by laboratory test value
Time frame: 52 weeks
Ran from Jun 2017 to primary completion in Sep 2018, 14 months.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Secondary →
Sanwa Kagaku Kenkyusho Co., Ltd.