The specified drug use study of tenapanor tablets,"study on the long-term use in hemodialysis patients"

The specified drug use study of tenapanor tablets,"study on the long-term use in hemodialysis patients" - The specified drug use study of tenapanor tablets

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058262

Enrollment

1000

Registered

2025-06-25

Start date

2024-03-01

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

Hypophosphatemia during hemodialysis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing hemodialysis who are initiating the use of this drug for the improvement of hyperphosphatemia in chronic kidney disease

Exclusion criteria

Exclusion criteria: Patients who are receiving peritoneal dialysis concurrently at the time of case registration

Design outcomes

Primary

Measure	Time frame
1. Safety (1) Incidence of adverse events (2) Incidence of adverse drug reactions, including infections (3) Considerations for safety specification (4) Examination of factors that may influence safety 2. Efficacy (1) Trends in serum phosphate (P) levels during the observation period (2) Efficacy rate based on the achievement of guideline-recommended serum P levels at the end of the observation period and throughout the observation period (3) Efficacy rates stratified by patient background (4) Examination of factors that may influence the assessment of efficacy	—

Measure

Time frame

1. Safety (1) Incidence of adverse events (2) Incidence of adverse drug reactions, including infections (3) Considerations for safety specification (4) Examination of factors that may influence safety 2. Efficacy (1) Trends in serum phosphate (P) levels during the observation period (2) Efficacy rate based on the achievement of guideline-recommended serum P levels at the end of the observation period and throughout the observation period (3) Efficacy rates stratified by patient background (4) Examination of factors that may influence the assessment of efficacy

—

Countries

Japan

Contacts

Public ContactChiemi Nishida

Kyowa Kirin Co.,Ltd. Pharmacovigilance division

chiemi.nishida.f4@kyowakirin.com03-5205-7200

Outcome results