Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
Status:
Completed
Trial end date:
2021-04-15
Target enrollment:
Participant gender:
Summary
The research is designed as a prospective, randomized, controlled clinical trial without
blinding. A total of 116 participants with hyperphosphatemia will be enrolled from three
hemodialysis center (56 from Huashan Hospital, 30 from Huadong Hospital and 30 from Tongji
Hospital). All participants will be randomly divided into control group and intervention
group in a ratio of 1:1. Phosphorus balance status is evaluated in participants of the
intervention group by the phosphorus balance calculator. Then, these participants will be
given individualized phosphate-binders, dietary and dialysis intervention according to the
results of phosphorus balance evaluation. Participants in the control group will not receive
the phosphorus balance status evaluation but receive phosphate-binder treatment according to
the KDIGO Guidelines. Dietary phosphorus intake, dialysate calcium concentration and dose of
active vitamin D, phosphorus-binders of all participants will be recorded during the whole
research program. After two-week treatment, the phosphorus balance of participants in
intervention group will be evaluated again and the therapeutic strategies then will be
adjusted. At the same time, the therapeutic strategies of participants in the control group
will be adjusted according to the serum phosphorus concentration. All participants will be
followed up for two weeks again and receive blood test and related examinations at the end of
study. The results of final examinations will be analyzed to evaluate the efficacy of
individualized treatment of hyperphosphatemia.
Phase:
Phase 3
Details
Lead Sponsor:
Chen Jing
Collaborators:
Huadong Hospital Shanghai Tongji Hospital, Tongji University School of Medicine