NCT03861247

Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients

Individualized Treatment of Hyperphosphatemia Based on Phosphate Balance in Maintenance Hemodialysis Patients: a Multicenter, Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Chen Jing · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Maintenance Hemodialysis
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	Phosphate-binder intervention	Use phosphate-binders according to KDIGO Guidelines, Chinese Guidance for Diagnosis and Treatment of Mineral and Bone Disorder in Chronic Kidney Disease and drug specification .
DIETARY_SUPPLEMENT	Phosphorus-restricted dietary intervention	Use low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary

Timeline

• Start date: 2019-11-29
• Primary completion: 2021-01-03
• Completion: 2021-04-15
• First posted: 2019-03-04
• Last updated: 2021-08-31

Locations

2 sites across 1 country: China