Effects of severe renal failure on the pharmacokinetics of irinotecan and its metabolite, and adverse drug events

Effects of severe renal failure on the pharmacokinetics of irinotecan and its metabolite, and adverse drug events - Relation between irinotecan pharmacokinetics and severe renal failure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000003602

Enrollment

Registered

2010-05-13

Start date

2005-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients had metastatic/recurrent, histologically confirmed solid tumors. 2. Patients did not receive irinotecan containing chemotherapy. 3. Eastern Cooperative Oncology Group performance status of 0 to 2. 4. Each patient was confirmed to have adequate bone marrow function (neutrocyte count, at least 1.5 x 109/L; platelet count, at least 100 x 109/L), liver function (serum bilirubin level, less than 1.5 mg/dL; transaminases, less than 2.0 times the upper limit of normal). 5. All patients signed a written informed consent form, granting permission for their peripheral blood samples and medical information to be used for research purposes.

Exclusion criteria

Exclusion criteria: 1. Patients who prohibited to receive irinotecan.

Design outcomes

Primary

Measure	Time frame
Ralation between renal function and irinotecan pharmacokinetics and adverse events	—

Countries

Japan

Outcome results