Hyperphosphatemia
Conditions
Interventions
Group 1:Dose: 1.5g each time for subjects taking the experimental drug and placebo, and 0.5g each time for subjects taking the control drug
D1 was administered once
D2-D12 was administered three times a day
D13 was administered once
Group 2:Dose: 3.0g each time for subjects taking the experimental drug and placebo, and 0.5g each time for subjects taking the control drug
Group 3:Dose: 4.5g each time for subjects taking the experimental drug and placebo, and 0.5g each time for subjects taking the control drug
Group 4:Dose: 6.0g each time for subjects taking the experimental drug and placebo, and 0.5g each time for subjects taking the control drug
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent before the trial, and fully understand the test content, process and possible adverse reactions; 2) Able to complete the study according to the requirements of the experimental program, able to accept dietary management and unified diet during the trial; 3) Regular hemodialysis was performed three times a week in the 12 weeks before screening (the total number of weeks without three times a week for special reasons should not exceed 2 weeks), and the dialysis regimen was expected to remain unchanged during the trial; 4) The patient is receiving appropriate dialysis treatment, and the urea clearance index (KT /V) >=1.2 (the KT /V value of the research center within one month before screening is valid, and the results of several measurements shall be subject to the latest measurement); 5) Subjects (including partners) are willing to voluntarily use effective contraceptive measures within 6 months from the screening to the last study drug administration, as detailed contraceptive measures are shown in Appendix 4; 6) Male and female subjects aged 18 to 65 years (including 18 and 65 years) with a body mass index (BMI) in the range of 18 to 35 kg/m2 (including the threshold); 7) In patients with end-stage renal disease hyperphosphatemia, fasting blood phosphorus >= 1.78mmol/L and <= 3.23mmol/L were measured at screening and admission.
Exclusion criteria
Exclusion criteria: 1) A history of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczema dermatitis) or known allergy to the experimental drug or similar drug; 2) Patients who had severe trauma or had undergone major surgery within 6 months prior to the trial, or who planned to undergo surgery during the study period were screened; 3) Blood loss > 450mL in the three months before screening; 4) Clinical, radiological or laboratory evidence of active tuberculosis (TB); 5) Previous kidney transplantation operations; 6) A history of drug use and/or alcohol abuse in the 3 months prior to screening (14 units of alcohol consumed per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine); 7) Those who were receiving any vitamin D or calcium-like regimens at the time of screening and could not maintain a stable dose after admission (except those who were receiving a stable vitamin D or calcium-like regimens); 8) Have dysphagia or gastrointestinal history with any influence on drug absorption, including but not limited to intestinal obstruction, macrocolon, habitual constipation (stool frequency = 4 times per day), gastroparesis with nausea or vomiting and other gastrointestinal disorders and gastrointestinal surgery; 9) suffer from any disease that increases the risk of gastrointestinal bleeding, such as acute erosive gastritis, acute hemorrhagic necrotizing enteritis, or active gastrointestinal ulcer; 10) For poorly controlled hypertension, the systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg should be measured at rest, and the patient should be rechecked at most twice for confirmation; 11) The history of acute coronary syndrome (such as myocardial infarction, unstable angina pectoris hospitalization), or percutaneous coronary intervention, or coronary artery bypass grafting in the previous 12 months was screened;Or had an arterial/venous thrombosis event, such as a cerebrovascular accident (including a history of stroke or transient ischemic attack), deep venous thrombosis and pulmonary embolism, within 12 months before screening; 12) Uncontrolled severe arrhythmias, such as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia, that were not controlled by medication or other treatment in the 12 months prior to enrolment; 13) Unstable and serious diseases of the digestive system, respiratory system, mental nervous system, endocrine system, blood system, malignant tumor, etc., which are not suitable for the study as judged by the study doctor; 14) Screening patients with a history of acute or severe infection within the previous 1 month; 15) Take phosphorus-reducing drugs, such as lanthanum carbonate, calcium carbonate, calcium acetate, aluminum hydroxide, Sveram, etc., within 14 days before administration;Drugs that may affect lanthanum ion release, such as proton pump inhibitors, H2 receptor antagonists, etc.And drugs that interact with experimental drugs, such as ciprofloxacin hydrochloride, thyroxine, lithium, etc.;Drugs containing phosphoric acid components, such as oseltamivir phosphate, sitagliptin phosphate tablets, etc. 16) Those who have participated in any clinical trials of drugs or medical devices within one month before taking the study drug; 17) During screening, hemoglobin <= 90g/L and albumin <= 30g/L; 18) Hypercalcem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phosphate concentrations;Plasma lanthanum concentrations; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24h Urinary phosphate concentrations;Plasma PTH concentrations;Plasma calcium concentrations; | — |
Countries
China
Contacts
Public ContactXiaoyan Wen
Grand Life Science (Liaoning) Co.,LTD
Outcome results
None listed