A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing He… (NCT02133404) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
Japan62 participantsStarted 2014-03-14
Plain-language summary
To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis
Who can participate
Age range20 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
* Patients with secondary hyperparathyroidism
* Patients whose serum iPTH concentration is \>240 pg/mL and corrected serum Ca is ≥ 9.0 mg/dL
* Patients who have had no changes in the following items ≥4-week (28 days).
* Dosage and regimen, including new administration, of active vitamin D, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods)
* Ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week
Exclusion Criteria:
* Patients who underwent parathyroid intervention, such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT), within 24 weeks (168 days) prior to the administration
* Patients who have primary hyperparathyroidism
* Patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days)
* Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are observed at \>2/3 of all confirmable measurements
* Patients who are complicated by severe heart disorder \[congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction\], or having a history of …
What they're measuring
1
Serum iPTH concentration
Timeframe: Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment