Back to resultsIndividualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
Primary Purpose
Maintenance Hemodialysis, Hyperphosphatemia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Phosphate-binder intervention
Phosphorus-restricted dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Maintenance Hemodialysis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Huadong Hospital, Fudan University
- Tongji Hospital, Tongji University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Intervention group
Arm Description
Outcomes
Primary Outcome Measures
Serum phosphorus concentration
Achievement rate of serum phosphorus
Secondary Outcome Measures
Serum calcium concentration
Serum iPTH concentration
Serum albumin concentration
Full Information
NCT ID
NCT03861247
First Posted
February 28, 2019
Last Updated
August 25, 2021
Sponsor
Chen Jing
Collaborators
Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03861247
Brief Title
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
Official Title
Individualized Treatment of Hyperphosphatemia Based on Phosphate Balance in Maintenance Hemodialysis Patients: a Multicenter, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
January 3, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chen Jing
Collaborators
Huadong Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maintenance Hemodialysis, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Phosphate-binder intervention
Intervention Description
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 .
Intervention Type
Dietary Supplement
Intervention Name(s)
Phosphorus-restricted dietary intervention
Other Intervention Name(s)
Additional dialysis intervention
Intervention Description
Use low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary
Primary Outcome Measure Information:
Title
Serum phosphorus concentration
Time Frame
Four weeks after treatment
Title
Achievement rate of serum phosphorus
Time Frame
Four weeks after treatment
Secondary Outcome Measure Information:
Title
Serum calcium concentration
Time Frame
Four weeks after treatment
Title
Serum iPTH concentration
Time Frame
Four weeks after treatment
Title
Serum albumin concentration
Time Frame
Four weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Huadong Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Tongji Hospital, Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
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