Chronic kidney disease undergoing hemodialysis Chronic kidney disease, Hemodialysis, and Hyperphosphatemia
Conditions
Interventions
Intervention 1: Treatment Aiming for Strict Serum Phosphorus Control versus Standard Serum Phosphate Management
Strict Serum Phosphate Control: Maintaining serum phosphate levels between 3.5 mg/dL and
Tenapanor, Strict Serum Phosphate Control
Sponsors
Nakatani Shinya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic kidney disease undergoing hemodialysis (including hemodiafiltration) for more than 90 days 2. Male and female patients aged 18 to 79 years 3. (1)Patients with a serum phosphate level of 5.5 mg/dL or higher without the use of phosphate-lowering agents. (2)Patients with a serum phosphate level of 4.5 mg/dL or higher while using phosphate-lowering agents. 4. Patients who have provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who have newly initiated oral bisphosphonates or selective estrogen receptor modulators (SERMs) for the treatment of osteoporosis within the past 90 days (patients who have been using these medications previously and have had only dosage adjustments in the past 90 days are not excluded). Patients with a history of administration of intravenous bisphosphonates, teriparatide, abaloparatide, denosumab, or romosozumab within the past 90 days, or who are scheduled to receive these agents during the study period, are excluded. 2. Patients who have newly initiated calcimimetics or active vitamin D analogs, either orally or intravenously, for the treatment of secondary hyperparathyroidism within the past 90 days. Patients who have switched formulations within the same drug class (e.g., from oral to intravenous or vice versa) are also excluded. However, patients who have undergone dosage adjustments only for previously used medications are not excluded. 3. Patients anticipated to have difficulty continuing the study due to planned surgeries, transfers to other facilities, or other reasons. 4. Patients with a known allergy to the investigational drug tenapanor (excluding abdominal symptoms such as diarrhea). 5. Patients with a history or concomitant diagnosis of inflammatory bowel disease or diarrhea-predominant irritable bowel syndrome. 6. Patients with a history of hospitalization for treatment (excluding hospitalization for diagnostic purposes) within the past 90 days. 7. Female patients who are pregnant, planning to become pregnant, within 28 days postpartum, or breastfeeding. 8. Patients with psychiatric disorders or symptoms that make study participation difficult as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in T50 before and after assigned treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measure Change in treatment satisfaction before and after assigned treatment Exploratory Outcome Measures Change in LPS-BP (lipopolysaccharide-binding protein) concentration before and after assigned treatment Changes in cholesterol metabolism marker concentrations before and after assigned treatment (Change in campesterol, sitosterol, desmosterol, and 7-ketocholesterol) Change in calprotectin concentration before and after assigned treatment Change in QT interval on electrocardiogram (ECG) before and after assigned treatment | — |
Contacts
Public ContactShinya Nakatani
Osaka Metropolitan University Hospital
Outcome results
None listed