Hyperphosphatemia in hemodialysis patients with chronic kidney disease (CKD)
Conditions
Interventions
Experimental group:Taking ferric citrate tablets according to clinical trial protocols.
Comparison group:Taking comparison tablets according to clinical trial protocols.
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Between the age of 18 and 75 years; no gender limitation; 2.Patients who maintain the hemodialysis schedule (including hemofiltration (HF) hemodialysis (HDF) hemoperfusion (HP)) as not less than 3 times a week in the 3 months before random enrollment. 3.Patients with a serum phosphorus level between 1.97 to 3.23 mmol/L (excluding the boundary value) after washout. 4.Kt/Vurea =1.2 or URR =65%. 5.Before the screening period, CKD-MBD related drug treatment is stable for more than one month, including the use of vitamin D (active vitamin D, vitamin D analogues, etc.) or calcimimetics (cinacalcet, etc.) and the dose remains unchanged. 6.The expected survival is greater than 6 months. 7.Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with a serum ferritin level =800 ng/mL or TSAT =50%. 2.Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with paroxysmal sleep hemoglobinuria. 3.Patients who received blood transfusions within 3 months prior to Screening, or patients with hemoglobin =60 g/L. 4.Patients with intact-PTH >1000 pg/mL. 5.Patients complicated with any of the following gastrointestinal diseases: acute peptic ulcer, chronic ulcerative colitis, localized enteritis, intestinal obstruction, habitual constipation (number of stools once per week), and chronic diarrhea (number of stools four times per day), or patients with a history of gastrectomy or enterectomy or patients who had undergone gastrointestinal surgery within 3 months prior to Screening, or patients with dysphagia. 6.Patients with impaired liver function (hepatic dysfunction or serum total bilirubin, aspartate aminotransferase or alanine aminotransferase = 2 times the upper limit of normal) or patients with cirrhosis. 7.Patients with a history of parathyroidectomy (PTx) or percutaneous anhydrous ethanol injection (PEIT) within 6 months. 8.Patients with uncontrolled diabetes or uncontrolled high blood pressure or current active infectious diseases such as active viral hepatitis. 9.Patients with a history of severe allergies may be allergic to research drugs. 10.Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification) requiring hospitalization within 6 months prior to Screening, or patients who use antiarrhythmic drugs to control arrhythmias or who use antiepileptic drugs to control seizures. 11.Patients who plan to receive a kidney transplant during the study period. 12.Patients with a history of drug and alcohol abuse. 13.Patients with active or advanced malignancy. 14.Women who are pregnant or lactating. 15.Patients complicated with active bleeding or requiring anticoagulation therapy with citrate in hemodialysis. 16.Patients who had participated in other clinical studies within 1 month prior to Screening. 17.Patients who are not suitable for participating in the trial according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum phosphorus levels from baseline serum phosphorus values at week 12 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Value of change from baseline in serum phosphorus levels at weeks 2, 4, 6, and 8 of treatment.;Area under the curve for serum phosphorus level-visit time (AUC0-12 weeks).;Blood phosphorus compliance at weeks 4, 6, 8, and 12 of treatment (compliance defined as blood phosphorus =1.78 mmol/L and =1.13 mmol/L).;Values of change from baseline in post-correction serum calcium concentration at weeks 4, 8, and 12 of treatment.;Change from baseline values of iPTH at weeks 4, 8, and 12 of treatment.; | — |
Countries
China
Contacts
Public ContactXuemei Li
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Outcome results
None listed