A Phase 3 interventional study of SK-1403 and Placebo 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 efficacy and safety of treatment with SK-1403 for 24 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 153 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (24 weeks), with individual dose adjustment.
Drug: SK-1403
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Drug: Placebo
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
Assessed by laboratory test value
Time frame: 24 weeks
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: 24 weeks
Measured values and Changes from baseline in serum PTH
Assessed by laboratory test value; unit of measure (pg/mL)
Time frame: 24 weeks
Measured values and Changes from baseline in Ca
Assessed by laboratory test value; unit of measure (mg/dL)
Time frame: 24 weeks
Measured values and Changes from baseline in ionized Ca
Assessed by laboratory test value; unit of measure (mEq/dL)
Time frame: 24 weeks
Measured values and Changes from baseline in P
Assessed by laboratory test value; unit of measure (mg/dL)
Time frame: 24 weeks
Measured values and Changes from baseline in serum Ca x P product
Assessed by laboratory test value
Time frame: 24 weeks
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.