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

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia; Maintenance Hemodialysis
• Intervention / Treatment: Drug: Phosphate-binder intervention; Dietary supplement: Phosphorus-restricted dietary intervention

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Huadong Hospital, Fudan University
    • Shanghai, Shanghai, China, 200000
      • Tongji Hospital, Tongji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject within 18-85 years old, male or female.
2. Subject receiving maintenance hemodialysis 3 times weekly at least 3 months with autologous arteriovenous fistula.
3. Subject with hyperphosphatemia as defined by serum phosphorus concentration >1.45mmol/L.
4. Subject in a good general condition with a stable dietary habit.
5. Subject has insight of the disease and treatment himself/herself and haves ability to communicate with others.
6. Subject has provided informed consent.

Exclusion Criteria:

1. Subject has residual renal function.
2. Subject with severe infection, anemia (Hb<60g/L) or hypoproteinemia (Alb<30g/L).
3. Subject has cancer or cachexia.
4. Subject with a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 3 months.
5. Subject with severe hematopoietic system disease, such as aplastic anemia, thalassemia and thrombocytopenic purpura.
6. Subject with severe gastrointestinal system disease such as dysphagia, hypohepatia, Active gastrointestinal bleeding, ileus, enterobrosis, or received subtotal gastrectomy.
7. 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.
8. Subject is pregnant.
9. 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.
10. Subject has inadequate hemodialysis with a recent spKt/V<1.2.
11. Subject has a poor nutritional status with a recent (nPNA<1.0g/kg/d) .
12. Subject is not a good participant for the research in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	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; Other Names: Additional dialysis intervention
Active Comparator: Control group	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum phosphorus concentration	Four weeks after treatment
Achievement rate of serum phosphorus	Four weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum calcium concentration	Four weeks after treatment
Serum iPTH concentration	Four weeks after treatment
Serum albumin concentration	Four weeks after treatment

Collaborators and Investigators

• Sponsor: Chen Jing
• Collaborators: Shanghai Tongji Hospital, Tongji University School of Medicine; Huadong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): January 3, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: KY-2018470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No