EPISODE

Not Applicable

• Conditions: hyperphosphatemia

• Registration Number: JPRN-jRCTs051180048
• Lead Sponsor: Isaka Yoshitaka

Brief Summary

We observed significant difference of percent change in CACS within Standard control and Strict control (p=0.006).Strict control may retard the progression of CACS among dialysis patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-05
• Study Completion: 2019-05-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

1.Patients with hyperphosphatemia in chronic maintenance dialysis.
2.Patients of the following serum P concentration before dialysis in observation period.
In the case of patients with medication, the phosphorus adsorbent in the observation period is serum P concentration of 5.0mg/dL or more.
In the case of patients with not medication, the phosphorus adsorbent in the observation period is serum P concentration of 6.1mg/dL or more.
3.Patients have elapsed dialysis after more than three months
4.Patients have received three times a week or more of stable hemodialysis (HD or HDF), and patients will continue to similar blood dialysis until the end of the treatment period start.
5.CACS of a patient is more than 30 that is measured during the observation period.
6.Patients are older 20-year-old or less than 80-year-old.
7.Outpatients
8.Gender does not matter.
9.Patients were obtained informed consent.

Exclusion Criteria

1.Before dialysis, serum intact-PTH concentration of previously registered one month is exceeds 800 pg/mL or over 500pg/mL, it is determined that the uncontrolled.
2.Patients have hemochromatosis or patients have a history of other iron storage disorders, or serum ferritin concentration before dialysis of the observation period at the start is over 300ng/mL or TSAT is more than 50%.
3.Patients have severe liver dysfunction (C chronic hepatitis, etc.).
4.Patients have severe coronary artery disease
5.Patients are merged malignant tumor.
6.Patients are paroxysmal nocturnal hemoglobinuria.
7.Patients have hypersensitivity iron-containing formulations or lanthanum-containing formulations.
8.Patients received PTX.
9.Patients suspect of being pregnant or pregnant.
10.Research investigators or research sharing investigators have determined to the patient is inappropriate as a subject of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of change in CACS

Secondary Outcome Measures

Name	Time	Method
1. changes in CACS, <br>2. changes in serum phosphate and calcium levels,changes in calcium phosphate product, and the ratio of patients who reached the target serum phosphate level, <br>3. changes in the level of intact parathyroid hormone (PTH), intact fibroblast growth factor (FGF)-23, and c-terminalFGF23, <br>4. effects on the renal anemia, assessed by transferrin saturation(TSAT), hemoglobin, and the changes in the dose of iron and EPO administration, <br>5. relationship between serum phosphate level and CACS, <br>6. average doses of phosphate binder required to achieve the target serum phosphate level, <br>7. safety issue (adverse drug reactions).