Hyperphosphatemia on hemodialysis with chronic kidney disease
Conditions
Interventions
Treatment Group:Sevelamer Carbonate Tablets
Control Group:Renvela
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, aged 18-70 years; 2.Definitely diagnosed as chronic kidney disease stage 5; 3.Hemodialysis was performed at least three times a week for 30 days or longer before randomization, and the dialysis; regimen remained the same during the trial; 4.Serum phosphorus concentration > 1.78mmol/L (5.5mg/dL); 5.If keep using vitamin D drugs before screening ,the dose should be stable for at least 1 month; 6.Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.If additional vitamin D medication is needed or the dose of vitamin D medication is changed during the trial; 2.Change the diet at will during the trial; 3.Uncontrolled diabetes mellitus, uncontrolled hypertension (pre-dialysis SBP > 180mmHg, DBP > 110mmHg), active infection, HIV positive history, and any other condition with clinical significant abnormalities; 4.Serum iPTH > 800pg/ml; 5.Dysphagia or difficulty swallowing; 6.Histories of intestinal dysfunction including intestinal obstruction (including paralytic intestinal obstruction, mechanical intestinal obstruction), megacolon, habitual constipation (stool frequency = 4 times/day), etc.; 7.Gastroparesis with symptoms of nausea or vomiting; 8.Have a history of gastric bowel operation, except appendectomy or polyp extirpate; 9.Active autoimmune diseases, such as systemic lupus erythematosus, vasculitis, etc., especially in patients with combined use of hormones and immunosuppressive agents; 10.Liver dysfunction,TBIL,AST or ALT more than 2 times the upper limit of normal value; 11.Subjects are using antiarrhythmic drugs (quinidine, amiodarone, procaine) or antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate) or antipsychotic drugs; 12.Diagnostic evidence of active, advanced malignancy; 13.Subjects had a history of alcohol and drug abuse; 14.Pregnant or lactating women; 15.Clearly have a history of allergies to the Investigational product; 16.A kidney transplant is planned within 3 months after the screening period; 17.Participated in clinical studies of other drugs within 1 month; 18.Poor compliance, unable to complete the experiment according to the scheme; 19.Subjects with acute kidney injury; 20.Subjects underwent parathyroidectomy within half a year; 21.The investigator believes there are any individuals who are unfit to participate in de trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum phosphorus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intact Parathyroid Hormone;blood lipid; | — |
Countries
China
Contacts
Public ContactDing Xiaoqiang
Zhongshan Hospital, Fudan University
Outcome results
None listed