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Study on control of serum phosphorus concentration with phosphorus lowering drugs in dialysis patients

Retrospective clinical study on control of serum phosphorus concentration with tenapanor and calcium carbonate in hemodialysis patients - Retrospective clinical study on control of serum phosphorus concentration with tenapanor and calcium carbonate in hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055181
Enrollment
20
Registered
2024-12-31
Start date
2024-08-08
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

Patients on hemodialysis

Interventions

None listed

Sponsors

Social medical corporation Kawashimakai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Maintenance hemodialysis cases and maitenance hemodiafiltration cases as of July 9, 2024 2 Patients who switched from lanthanum carbonate to tenapanor

Exclusion criteria

Exclusion criteria: 1 Patients who underwent dialysis treatment conditions different from those as of July 9, 2024 between April 1, 2024 and July 9, 2024 2 Patients whose dialysis time was less than 3 hours/session and whose dialysis frequency was other than 3 sessions/week 3 Patients who used a blood purification method other than HD or OHDF 4 Patients with serum phosphorus concentration 7.1mg/dL or higher 5 Patients who were prescribed phosphorus-reducing drugs other than lanthanum carbonate and calcium carbonate 6 Patients with medication adherence problems 7 Patients who could not continue due to side effects during the period 8 Patients who received denosumab or romosozumab within 2 months of the start of the study 9 Patients who plan to use denosumab during the study period 10 Patients who received a calcium receptor agonist or bisphosphonates for the first time or had their dose changed within 2 months before the start of the study 11 Patients who received a calcium receptor agonist, romosozumab, denosumab, or bisphosphonates for the first time or had their dose changed during the study period 12 Patients who were hospitalized for more than one week during the study period. 13 Patients who did not take Tenapanor properly through interviews conducted during the study period 14 Patients who experienced loss of appetite 15 Patients with a dry weight decrease or increase of 1 kg or more in the 2 months prior to the start of the study

Design outcomes

Primary

MeasureTime frame
1 Number of tablets of phosphorus-reducing drugs at the start and after 12 weeks 2 Changes in serum phosphorus concentration and tenapanol dosage over 12 weeks

Secondary

MeasureTime frame
1. Number of patients prescribed calcium carbonate, number of patients prescribed active vitamin D analogs, serum corrected calcium concentration, and intact PTH value at the start and 12 weeks after treatment 2. Incidence rate of side effects

Countries

Japan

Contacts

Public ContactManabu Tashiro

Social medical corporation, Kawashimakai, Kawashima hospital Department of Nephrology

m.tashiro@khg.or.jp0886310110

Outcome results

None listed

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