Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients

NCT03861247 | Completed Phase 3

• 1 other identifier: KY-2018470
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Maintenance Hemodialysis; Hyperphosphatemia

Outcome Measures

Primary Outcomes (2)

• Serum phosphorus concentration

  Four weeks after treatment

• Achievement rate of serum phosphorus

  Four weeks after treatment

Secondary Outcomes (3)

• Serum calcium concentration

  Four weeks after treatment

• Serum iPTH concentration

  Four weeks after treatment

• Serum albumin concentration

  Four weeks after treatment

Study Arms (2)

Control group

ACTIVE COMPARATOR

Drug: Phosphate-binder intervention

Intervention group

EXPERIMENTAL

Drug: Phosphate-binder intervention; Dietary Supplement: Phosphorus-restricted dietary intervention

Interventions

Phosphate-binder intervention DRUG

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 .

Control group; Intervention group

Phosphorus-restricted dietary intervention DIETARY_SUPPLEMENT

Use low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary

Also known as: Additional dialysis intervention

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Jing: lead
• Huadong Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator

Study Sites (2)

Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: November 29, 2019
• Primary Completion: January 3, 2021
• Study Completion: April 15, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)