Status:
COMPLETED
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
Lead Sponsor:
Chen Jing
Collaborating Sponsors:
Huadong Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Conditions:
Maintenance Hemodialysis
Hyperphosphatemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 (5...
Eligibility Criteria
Inclusion
- Subject within 18-85 years old, male or female.
- Subject receiving maintenance hemodialysis 3 times weekly at least 3 months with autologous arteriovenous fistula.
- Subject with hyperphosphatemia as defined by serum phosphorus concentration \>1.45mmol/L.
- Subject in a good general condition with a stable dietary habit.
- Subject has insight of the disease and treatment himself/herself and haves ability to communicate with others.
- Subject has provided informed consent.
Exclusion
- Subject has residual renal function.
- Subject with severe infection, anemia (Hb\<60g/L) or hypoproteinemia (Alb\<30g/L).
- Subject has cancer or cachexia.
- Subject with a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 3 months.
- Subject with severe hematopoietic system disease, such as aplastic anemia, thalassemia and thrombocytopenic purpura.
- Subject with severe gastrointestinal system disease such as dysphagia, hypohepatia, Active gastrointestinal bleeding, ileus, enterobrosis, or received subtotal gastrectomy.
- Subject with disease which affects serum phosphorus concentration such as hypoparathyroidism (iPTH\<11pg/ml), severe hyperparathyroidism (iPTH\>600pg/ml) and type 2 vitamin D dependence rickets.
- Subject is pregnant.
- Subject is currently enrolled in or has completed any other investigational device or drug study\<30 days prior to screening, or is receiving other investigational agents.
- Subject has inadequate hemodialysis with a recent spKt/V\<1.2.
- Subject has a poor nutritional status with a recent (nPNA\<1.0g/kg/d) .
- Subject is not a good participant for the research in the opinion of the investigator.
Key Trial Info
Start Date :
November 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03861247
Start Date
November 29 2019
End Date
April 15 2021
Last Update
August 31 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
2
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, China, 200000