Hyperphosphatemia in dialysis patients with chronic kidney disease
Conditions
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 or above, male or female 2) Patients with clinically diagnosed chronic kidney disease (CKD) who have received hemodialysis or peritoneal dialysis treatment and have been on stable dialysis for =3 months; 3) had not been treated with phosphorus binders before screening, and blood phosphorus was >1.45 mmol/L (>4.5 mg/dL); Or the maximum dose of the original phosphorus binder was used for at least 4 weeks before screening, but the blood phosphorus was still > 1.45mmol /L; Or the researchers assessed that the benefits of the original phosphorus binding agent were greater than the disadvantages due to adverse reactions and other reasons, and the blood phosphorus after elution was >1.45 mmol/L; 4) The subjects voluntarily joined the study, were able to understand the study requirements, and signed the informed consent
Exclusion criteria
Exclusion criteria: 1) People who are allergic to saccharose hydroxy-iron oxide chewable tablets related ingredients or excipients 2) hemochromatosis and any other iron accumulation disorder; 3) Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency; 4) Expected survival 2 times the upper limit of normal; 8) Acute or chronic diarrhea; 9) Patients determined by the investigator to be unable to participate in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with blood phosphorus =1.78mol/L;Changes in blood phosphorus levels relative to baseline (absolute, percentage); | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood calcium level;iPTH level;Percentage of patients with blood phosphorus =1.78mol/L;Percentage of patients with blood phosphorus =1.45mol/L;Changes in blood phosphorus levels relative to baseline (absolute, percentage);Iron indicators (serum iron, ferritin, transferrin, iron binding capacity);Bone metabolic markers (FGF-23, 25OHVitD, 1,25(OH)2VitD, ß-cTX, osteocalcin, bone-specific alkaline phosphatase);Progress of vascular calcification;Changes in bone mineral density from baseline;Patient quality of life score;Changes in pruritus from baseline;Changes in muscle strength from baseline;Changes in patients' muscle-related laboratory indicators from baseline;Skeletal muscle changes from baseline;Incidence of adverse cardiovascular events (MACE);Medication dose (tablet load) and medication adherence; | — |
Countries
China
Contacts
Public ContactXIAOQIANG DING
Zhongshan Hospital, Fudan University
Outcome results
None listed