Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients (NCT03861247) | Clinical Trial Compass
CompletedPhase 3
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
China123 participantsStarted 2019-11-29
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.