Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Phase 2
Completed
- Conditions
- Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
- Interventions
- Registration Number
- NCT02753894
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to examine the clinical dose range of ASP1585 based on the efficacy, safety, and feasibility of treatment in chronic kidney disease patients on hemodialysis with hyperphosphatemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
For preliminary enrollment
- Patients with stable chronic kidney disease who received hemodialysis 3 times a week for at least 12 weeks (84 days) prior to the day of preliminary enrollment
- Patients who did not have dialysis conditions altered (dialysate calcium concentration, dialyser, and dry weight) within 10 days prior to the day of preliminary enrollment
- Patients who did not have the following dosage or administration altered at least 28 days prior to the day of preliminary enrollment: phosphate binders, or drugs/food with phosphate binding action (including newly started treatment)
- If receiving vitamin D or calcitonin agent, patients who did not have dosage and administration altered (including newly started treatment) for at least 28 days prior to the day of preliminary enrollment.
- Patients who did not use cinacalcet hydrochloride for at least 28 days prior to the day of preliminary enrollment
For practical enrollment
- Patients whose pre-dialysis serum phosphorus level after the maximum dialysis interval at Week 1 of the washout period was ≥8.0 mg/dL and <10.0 mg/dL or that at Week 2 was ≥6.0 mg/dL and <10.0 mg/dL
- Patients who continued to receive hemodialysis 3 times a week after the day of preliminary enrollment
- Patients who did not have dialysis conditions altered (dialysate calcium concentration and dialyser) after the day of preliminary enrollment
- Patients who did not receive phosphate binders, or drugs/food with phosphate binding action during the washout period
- If receiving vitamin D or calcitonin agent (including start of new treatment) after the day of preliminary enrollment, patients who did not have dosage and administration altered for at least 28 days prior to the day of preliminary enrollment
- Patients who did not use cinacalcet hydrochloride after the day of preliminary enrollment
Exclusion Criteria
For preliminary enrollment
- Patients with a history of gastrectomy or enterectomy (except for appendectomy) or with a complication of dysphagia, ileus, or hemorrhagic gastrointestinal lesions
- Patients with severe persistent constipation or diarrhoea
- Patients who underwent parathyroid intervention (parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT], etc.) within 1 year prior to the day of preliminary enrollment
- Patients who are fasted or are on extreme dietary restrictions
- Patients with uncontrollable hypertension (all the last 3 measurement values of pre-dialysis systolic/diastolic blood pressure before the day of preliminary enrollment are ≥180 mmHg and ≥120 mmHg, respectively)
- Patients with severe heart disease (congestive heart failure [NYHA cardiac function classification Class III or severer], a history of extensive old myocardial infarction, etc.) or patients who were hospitalized for the treatment of cerebrovascular disease or heart disease within 12 weeks (84 days) prior to the day of preliminary enrollment
- Patients with a complication of serious hepatic disease (acute and active chronic hepatitis, hepatic cirrhosis, etc.)
- Patients with a history of serious drug hypersensitivity, such as anaphylactic shock
- Patients with a history or complication of malignant tumor (considered eligible if recurrence has not been observed for at least 5 years)
- Patients who are pregnant, nursing, suspected to be pregnant, or wish to become pregnant during the study period
- Patients who have previously received ASP1585
- Patients who participated in another clinical study or a post-marketing clinical study (including that of a medical device) within 12 weeks (84 days) prior to informed consent
For practical enrollment
- Patients whose pre-dialysis serum phosphorus level after the maximum dialysis interval at Week 1 or 2 of the washout period was ≥10 mg/dL
- Patients who underwent gastrectomy or enterectomy, or had dysphagia, ileus, or hemorrhagic gastrointestinal lesions after the day of preliminary enrollment
- Patents who had severe persistent constipation or diarrhoea after the day of preliminary enrollment
- Patients who underwent parathyroid intervention (parathyroidectomy [PTx], percutaneous ethanol injection therapy [PEIT], etc.) after the day of preliminary enrollment
- Patients who were fasted or on extreme dietary restriction after the day of preliminary enrollment
- Patients with uncontrollable hypertension (more than two thirds of pre-dialysis systolic/diastolic blood pressure values were ≥180 mmHg and ≥120 mmHg, respectively, after the day of preliminary enrollment)
- Patients with severe heart disease (congestive heart failure [NYHA cardiac function classification Class III or severer], etc.) or patients who were hospitalized for the treatment of cerebrovascular disease or heart disease after the day of preliminary enrollment
- Patients with a complication of impaired liver function (baseline AST or ALT was 100 IU/L or higher) or serious hepatic disease (acute and active chronic hepatitis, liver cirrhosis, etc.)
- Patients who experienced serious drug hypersensitivity such as anaphylactic shock after the day of preliminary enrollment
- Patients with a complication of malignant tumor
- Patients who were found to be pregnant after the day of preliminary enrollment
- Patients who participated in another clinical study or a post-marketing clinical study (including that of a medical device) after the day of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4.5 g/day group ASP1585 Three times a day 6.0 g/day group ASP1585 Three times a day 7.5 g/day group ASP1585 Three times a day
- Primary Outcome Measures
Name Time Method Change from the baseline of serum phosphorus level Baseline and Week 6 Safety assessed by Blood biochemistry tests Up to 6 weeks after the study drug dosing Safety assessed by Blood cogulability tests Up to 6 weeks after the study drug dosing Safety assessed by Hematology test Up to 6 weeks after the study drug dosing Safety assessed by AEs Up to 6 weeks after the study drug dosing Blood concentration of Vitamin Up to 6 weeks after the study drug dosing Safety assessed by Vital signs Up to 6 weeks after the study drug dosing Systolic blood pressure, diastolic blood pressure, heart rate
Safety assessed by bowel movement Up to 6 weeks after the study drug dosing Safety assessed by ECG Up to 6 weeks after the study drug dosing
- Secondary Outcome Measures
Name Time Method Time course of serum phosphorus level Up to Week 6 Time course of corrected serum calcium level Up to Week 6 Time course of calcium-phosphorus product Up to Week 6 Time course of intact parathyroid hormone Up to Week 6 Percentage of subjects who achieved the target serum phosphorus level (3.5 to 6.0 mg/dL) Up to Week 6 Time achievement of the target serum phosphorus level (3.5 to 6.0 mg/dL) Up to Week 6
Trial Locations
- Locations (11)
Site JP00006
🇯🇵Ibaraki, Japan
Site JP00008
🇯🇵Ibaraki, Japan
Site JP00002
🇯🇵Miyagi, Japan
Site JP00007
🇯🇵Ibaraki, Japan
Site JP00011
🇯🇵Aichi, Japan
Site JP00003
🇯🇵Nagano, Japan
Site JP00004
🇯🇵Nagano, Japan
Site JP00001
🇯🇵Miyagi, Japan
Site JP00009
🇯🇵Chiba, Japan
Site JP00010
🇯🇵Chiba, Japan
Site JP00005
🇯🇵Nagano, Japan