Patients who presented delayed excretion of MTX after HD-MTX administration
Conditions
Interventions
investigational material(s)
Generic name etc : Glucarpidase (genetical recombination)
INN of investigational material : -
Therapeutic category code : 392 Antidotes
Dosage and Administration for Invest
Sponsors
Ohara Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A written consent for participation in the clinical study was obtained by patients themselves or their legal representative 2) Fifteen hours or more have passed since administration of MTX and one of the following criterion (1) to (4) is met: (1) a blood MTX concentration > 50 umol/L at 22 hours or more after the start of MTX infusion (2) a blood MTX concentration > 5 umol/L at 40 hours or more after the start of MTX infusion (3) a blood MTX concentration > 2 umol/L at 46 hours or more after the start of MTX infusion (4) a blood MTX concentration > 1 umol/L at 40 hours or more after the start of MTX infusion, and have a sign of acute renal failure*. * Acute renal failure is defined as meeting either of the following (i) to (iii): (i) The serum creatinine after the start of MTX administration is higher than the upper limit of the pediatric reference in the site (if absent, Toshiaki Tanaka, Pocket Guide for Reference Laboratory Values in Children, second edition, Jiho) (ii) Increase to 1.5 times or more the serum creatinine before the start of MTX administration (iii) Increase of 0.3 mg/dL or more in the serum creatinine within 48 hours before enrollment
Exclusion criteria
Exclusion criteria: 1) Subjects who have a history of hypersensitivity against contained excipients (lactose hydrate, trometamol, zinc acetate dihydrate, and hydrochloric acid) 2) Subjects who are using loop diuretics or mannitol, and can't discontinue them 3) Subjects who are recieved hemodialysis or plasmapharesis, and can't discontinue them 4) Subjects who are recieved MTX (any route of administration) after IV HD-MTX 5) Subjects who are previously treated with investigational drug 6) Subjects with severe cardiac disease 7) Subjects who are pregnant or nursing, and can't prevent conception during follow-up period 8) Subjects who are judged to be inappropriate by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percent reduction of plasma MTX concentration at 20 minutes after the start of glucarpidase injection compared to immediately before injection | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy (1) The decreasing rate of the plasma MTX concentration (central measurement) at 2 to 96 hours after the investigational drug administration from the baseline immediately before administration (2) Time for the plasma MTX concentration (central measurement) to decrease to the threshold (1 umol/L) (3) Presence/absence of CIR achievement (4) Changes in plasma DAMPA concentration and changes in plasma MTX Concentration (5) Transition of blood MTX concentration by local laboratory safety (1) Adverse events (2) Vital signs (weight, body temperature, blood pressure, pulse rate) (3) 12-lead ECGs pharmacokinetics Transition of plasma glucarpidase concentration and PK parameters | — |
Countries
Japan
Outcome results
None listed