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NCT03861247
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
Phase 3 trial testing Phosphate-binder intervention in Maintenance Hemodialysis in 123 participants. Completed in 15 April 2021.
3 January 2021
Quick facts
| Lead sponsor | Chen Jing |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 123 |
| Start date | 29 November 2019 |
| Primary completion | 3 January 2021 |
| Estimated completion | 15 April 2021 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Phosphate-binder intervention — full drug profile →
- Phosphorus-restricted dietary intervention
Conditions studied
- Maintenance Hemodialysis — all drugs for Maintenance Hemodialysis →
- Hyperphosphatemia — all drugs for Hyperphosphatemia →
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:
- PubMed search for NCT03861247
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Chen Jing trials
Trials by the same sponsor.
- NCT07361783 — Impact of Pre-Hospital Heparin Loading in STEMI Patients for Primary PCI: The HELP-PCI 2 Trial · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03861247 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chen Jing
- Last refreshed: 31 August 2021
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