Efficacy of Tenapanor in Managing Hyperphosphatemia and Constipation in Hemodialysis Patients: A Prospective Cohort Study

UMIN ID: UMIN000056561

Registered date:25/12/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 2024/03/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention: Patients who started taking tenaponar. Treatment for 23 weeks. The starting dose was 10 mg/day, and the dose was adjusted by each treating physician according to the serum phosphorus level.
The type and dosage of medication will be increased or decreased by the treating physician depending on the serum phosphorus level.

Outcome(s)

• Primary Outcome: Changes in serum phosphorus levels, changes in phosphorus adsorbent, changes in stool characteristics (Bristol Stool Characteristics Score), and changes in laxative prescription during the observation period.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria were as follows; (1) patients had to have been undergoing hemodialysis for at least 2 years at baseline, (2) Patients with a history of or current inflammatory bowel disease or diarrhea-type irritable bowel syndrome, and (3) CRP was 1.0 mg/dL or higher.

Related Information

• Primary Sponsor: Tojinkai Hospital
• Source(s) of Monetary Support: None