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Safety Study of Reduced-Dose 5-Aminolevulinic Acid Administration in Elderly Patients with Renal Impairment

A Safety Evaluation of Reduced-Dose 5-Aminolevulinic Acid Administration During Bladder Tumor Surgery in Elderly Patients with Renal Impairment

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250795
Enrollment
30
Registered
2026-03-11
Start date
2026-03-11
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

Bladder tumor in elderly patients with renal impairment bladder tumor

Interventions

When performing PDD-TURBT in elderly patients with bladder tumor and renal impairment, the dose of 5-aminolevulinic acid is reduced from 20 mg/kg to 10 mg/kg.

Sponsors

Miyakawa University Jinpei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with bladder tumor scheduled for PDD-TURBT (2) Patients confirmed to have an eGFR of less than 45 at least once within the last 12 weeks (3) Age: Patients aged 80 years or older at the time of obtaining consent (4) Gender: Both sexes (5) Patients who have received sufficient explanation regarding participation in this study, fully understood the contents, and provided written informed consent of their own free will (6) Patients capable of hospitalization according to the study schedule

Exclusion criteria

Exclusion criteria: (1) Patients with a history of hypersensitivity to 5-aminolevulinic acid or porphyrins (2) Patients with porphyria (3) Patients with a history of hypotension caused by the use of 5-aminolevulinic acid (4) Other patients judged ineligible for participation in this study by the principal investigator or sub-investigator

Design outcomes

Primary

MeasureTime frame
Incidence rate of composite events (severe hypotension or hepatic impairment) during the perioperative period

Secondary

MeasureTime frame
(1) Perioperative hypotension (2) Incidence rate of perioperative hepatic impairment (3) Amount of vasopressors (Phenylephrine, ephedrine) used intraoperatively (4) Sensitivity and specificity of lesion detection compared with white-light TURBT

Contacts

Public ContactJinpei Miyakawa

The University of Tokyo Hospital

MIYAKAWAJ-URO@h.u-tokyo.ac.jp+81-338155411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026