An observational study in Acute Kidney Injury and Drug Toxicity, sponsored by Protherics Medicines Development Limited. Status unknown at 5 sites in 3 countries. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Protherics Medicines Development Limited · Observational
This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of methotrexate, acute kidney injury and any associated impact of delayed elimination of methotrexate on future courses of chemotherapy and disease outcomes in adults and children with cancer.
The study will compare current practice with existing guidelines and best practices to identify potential gaps in the management of high-dose methotrexate administration and delayed elimination of methotrexate. The study will identify variations in practice and outcomes in different study centers, countries, cancer types, patient age groups, by different methotrexate doses and infusion times and different supportive care measures used. The study will also document the proportion of high-dose methotrexate courses in which glucarpidase has been used and any toxicities attributable to the use of glucarpidase.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →This is the only study on the registry with Protherics Medicines Development Limited as lead sponsor.
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The study will be conducted at approximately 10 European sites where high-dose methotrexate infusions are administered. Sites will be selected to ensure a balanced accrual of children and adults treated with high-dose methotrexate.
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Exclusion Criteria:
Patients with a diagnosis of any cancer receiving high-dose methotrexate chemotherapy.
Drug: High-dose methotrexate · Drug: Glucarpidase
High-dose methotrexate
Glucarpidase
Delayed Elimination of Methotrexate
Incidence of delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined by Ramsey criteria.
Time frame: 0-48 hours from the start of high-dose methotrexate infusion.
Acute Kidney Injury
Incidence of acute kidney injury of any grade after high-dose methotrexate chemotherapy.
Time frame: 0-48 hours from the start of high-dose methotrexate infusion.
Severe Delayed Elimination of Methotrexate
Incidence of severe delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined as a methotrexate level ≥2 standard deviations above the population mean at 36, 42, or 48 hours from the start of high-dose methotrexate infusion and with the presence of acute kidney injury of any grade.
Time frame: 0-48 hours from the start of high-dose methotrexate infusion.
Severity of Acute Kidney Injury
Severity of occurrences of acute kidney injury using CTCAE v5 criteria.
Time frame: 0-48 hours from the start of high-dose methotrexate infusion.
Hospital Length of Stay
Duration of hospitalization.
Time frame: Assessed through study completion, up to 2 years after enrollment.
Hospital Readmission
Incidence of hospital readmission.
Time frame: Within 14 days of high-dose methotrexate infusion.
Delay of Subsequent Chemotherapy
Occurrence of delays to further blocks of chemotherapy resulting from delayed methotrexate elimination.
Time frame: Within 14 days of high-dose methotrexate infusion.
Dose Reduction or Omission of Subsequent High-dose Methotrexate Therapy
Occurrence of dose reduction or omission of high-dose methotrexate from further cycles of chemotherapy resulting from delayed methotrexate elimination.
Time frame: Within 14 days of high-dose methotrexate infusion.
Event-Free Survival
"Events" include death, relapse, abandonment, or refusal of treatment.
Time frame: 3, 5, and 10 years.
Overall Survival
All-cause mortality as well as mortality separately due to disease progression or toxicity.
Time frame: 3, 5, and 10 years.
Glucarpidase-Related Toxicity
Occurrence of toxicities associated with glucarpidase, including frequency, severity (using CTCAE v5 criteria) and including documenting any toxicities of grade 3 or higher.
Time frame: 15 minutes post-glucarpidase through discharge.
Methotrexate Clearance after Glucarpidase
MTX levels.
Time frame: 15 minutes post-glucarpidase through discharge.
Serum Creatinine Level
Renal function, as measured by serum creatinine level.
Time frame: 15 minutes post-glucarpidase through discharge.
Use of Subsequent High-Dose Methotrexate After Glucarpidase
Occurrence of subsequent high-dose methotrexate chemotherapy cycles given after glucarpidase.
Time frame: Within 14 days of high-dose methotrexate infusion.
Disease Outcome After Glucarpidase
Disease outcome after glucarpidase
Time frame: 3, 5, and 10 years.
Use of Hyperhydration
Incidence of the use of hyperhydration supportive care measures during high-dose methotrexate chemotherapy.
Time frame: Assessed at time of hospital discharge.
Use of Leucovorin
Incidence of the use of leucovorin during high-dose methotrexate chemotherapy.
Time frame: Assessed at time of hospital discharge.
Use of Dialysis or Hemofiltration
Incidence of the use of dialysis or hemofiltration during high-dose methotrexate chemotherapy.
Time frame: Assessed at time of hospital discharge.
Use of Oral Methotrexate Binders
Incidence of the use of oral methotrexate binders (cholestyramine, activated charcoal) during high-dose methotrexate chemotherapy.
Time frame: Assessed at time of hospital discharge.
Creatinine Clearance
Renal function, as measured by creatinine estimate
Time frame: 15 minutes post-glucarpidase through discharge.
Need for Dialysis
Renal function, as measured by need for dialysis.
Time frame: 15 minutes post-glucarpidase through discharge.
Started Apr 2022 (actual). Primary completion is estimated for Aug 2024, 28 months after the start.
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This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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