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NCT Number: NCT03861247

Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients

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.

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Key information

Conditions

Maintenance Hemodialysis Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huadong Hospital, Fudan University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Phosphorus-restricted dietary intervention

Dietary Supplement

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

Other names: Additional dialysis intervention

Primary outcomes

  1. Serum phosphorus concentration

    Time frame: Four weeks after treatment

  2. Achievement rate of serum phosphorus

    Time frame: Four weeks after treatment

Secondary outcomes

  1. Serum calcium concentration

    Time frame: Four weeks after treatment

  2. Serum iPTH concentration

    Time frame: Four weeks after treatment

  3. Serum albumin concentration

    Time frame: Four weeks after treatment

Sponsors and collaborators

Lead sponsor

Chen Jing

Other

Collaborators

  • Huadong Hospital
  • Shanghai Tongji Hospital, Tongji University School of Medicine

Registry information

Official study title

Individualized Treatment of Hyperphosphatemia Based on Phosphate Balance in Maintenance Hemodialysis Patients: a Multicenter, Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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