Last reviewed · How we verify

NCT03861247

Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients

Completed Phase 3 Last updated 31 August 2021
What this trial tests

Phase 3 trial testing Phosphate-binder intervention in Maintenance Hemodialysis in 123 participants. Completed in 15 April 2021.

Timeline
29 November 2019
Primary endpoint
3 January 2021
15 April 2021

Quick facts

Lead sponsorChen Jing
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment123
Start date29 November 2019
Primary completion3 January 2021
Estimated completion15 April 2021
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Chen Jing — full company profile →

Who can join

Adults 18 to 85, any sex, with Maintenance Hemodialysis or Hyperphosphatemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Maintenance Hemodialysis

Currently open trials in the same condition.

Other Chen Jing trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03861247.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing