A Phase 1 interventional study of ASP3325 in Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis, sponsored by Astellas Pharma Inc. Completed at 5 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment
The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal
[Part 1] This part is an open-label, uncontrolled study to evaluate PK and safety with single dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication for hyperphosphatemia, six subjects will receive single oral administration of ASP3325 (Tablet A) on a non-dialysis day (Day 1).
[Part 2] This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety with dosing ASP3325 Tablet B t.i.d. before or just after each meal.
Eligible subjects at screening will be entered into the washout period for stopping their phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between ≥6.0 and \<10.0 mg/dL during the washout period (washout period week 1 or washout period week 2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks until Day 14.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 24 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
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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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASP3325 tablets A will be orally administered with 150 mL of water in fasting condition on non-dialysis day in Day 1
Drug: ASP3325
ASP3325 tablets B will be orally administered t.i.d. 30 minutes before each meal for 2 weeks
Drug: ASP3325
ASP3325 tablets B will be orally administered t.i.d. 30 minutes just after each meal for 2 weeks
Drug: ASP3325
oral
Safety assessed by adverse events: Part 1
Time frame: Up to Day 7
Safety assessed by adverse events: Part 2
Time frame: Up to Day 22
Safety assessed by vital signs: Part 1
Vital signs include body temperature, blood pressure and pulse rate)
Time frame: Up to Day 7
Safety assessed by vital signs: Part 2
Vital signs include body temperature, blood pressure and pulse rate)
Time frame: Up to Day 22
Safety assessed by clinical laboratory test: Part 1
Clinical laboratory tests include hematology and biochemistry
Time frame: Up to Day 7
Safety assessed by clinical laboratory test: Part 2
Clinical laboratory tests include hematology and biochemistry
Time frame: Up to Day 22
Safety assessed by 12-Lead ECG: Part 1
ECG: electrocardiogram
Time frame: Up to Day 7
Safety assessed by 12-Lead ECG: Part 2
ECG: electrocardiogram
Time frame: Up to Day 22
Cmax of unchanged ASP3325
Cmax:maximum plasma concentration
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
tmax of unchanged ASP3325
tmax = time to reach maximum plasma concentration
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUClast of ASP3325
AUClast: Area under the Curve of plasma concentration during observation period in each observational day
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUCinf of ASP3325
AUCinf: Area under the Curve of plasma concentration
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
t1/2 of ASP3325
t1/2 = apparent terminal elimination half-life
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Vz/F of ASP3325
Vz/F = apparent volume of distribution
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
CL/F of ASP3325
CL/F = oral clearance
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Ctrough of ASP3325
Ctrough = observed trough concentration
Time frame: Part 2 Before administration, Day 3, 5, 8, 10, 12, 15 and 22
Serum Pi of ASP3325
Serum Pi: serum phosphate concentration before dialysis
Time frame: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum Calcium (adjusted for albumin)
Corrected value of Calcium (Ca) (mg/dL) = Observed value of Ca (mg/dL) + \[4-albumin (g/dL)
Time frame: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum concentration of intact PTH before dialysis
PTH = parathyroid hormone
Time frame: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Serum concentration of FGF23
FGF23 = fibroblast growth factor 23
Time frame: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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