A Phase 3 interventional study of SK-1403 in Secondary Hyperparathyroidism, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 3, Interventional, and Treatment
To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's enrollment of 157 is above 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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Exclusion Criteria:
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.
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
Drug: SK-1403
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
Number of participants with adverse events or adverse drug reactions
Number of participants with adverse events or adverse drug reactions
Time frame: 52 weeks
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point; Assessed by laboratory test value
Time frame: 52 weeks
Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product
Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value
Time frame: 52 weeks
Ran from Sep 2018 to primary completion in Feb 2020, 16 months.
Of 21 phase 3 interventional studies under Hyperparathyroidism, Secondary, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 31. This study's 16 months is below that.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Upacicalcet
Hyperparathyroidism, Secondary →
Sanwa Kagaku Kenkyusho Co., Ltd.