Hyperphosphatemia
Conditions
Brief summary
The aim of the study is: To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses； To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple administration.
Interventions
DRUGLanthanum Polystyrene Sulphonate Powder
D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
DRUGLanthanum Carbonate 500 MG
D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
DRUGPlacebo
D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
Sponsors
The First Hospital of Jilin University
Grand Life Science (Liaoning) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(Only if all the criteria are met): * 1\) Sign the informed consent before the trial, and fully understand the test content, process and possible adverse reactions; * 2\) Able to complete the study according to the requirements of the experimental program, able to accept dietary management and unified diet during the trial; * 3\) Regular hemodialysis was performed three times a week in the 12 weeks before screening (the total number of weeks without three times a week for special reasons should not exceed 2 weeks), and the dialysis regimen was expected to remain unchanged during the trial; * 4\) The patient is receiving appropriate dialysis treatment, and the urea clearance index (KT /V) ≥1.2 (the KT /V value of the research center within one month before screening is valid, and the results of several measurements shall be subject to the latest measurement); * 5\) Subjects (including partners) are willing to voluntarily use effective contraceptive measures within 6 months from the screening to the last study drug administration, as detailed contraceptive measures are shown in Appendix 4; * 6\) Male and female subjects aged 18 to 65 years (including 18 and 65 years) with a body mass index (BMI) in the range of 18 to 35 kg/m2 (including the threshold); * 7\) In patients with end-stage renal disease hyperphosphatemia, fasting blood phosphorus ≥1.78mmol/L and ≤3.23mmol/L were measured at screening and admission.
Exclusion criteria
(If one of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood phosphate concentrations | At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17） |
| Plasma lanthanum concentrations | At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17） |
Secondary
| Measure | Time frame |
|---|---|
| 24h Urinary phosphate concentrations | At pre-defined intervals from initial dose through final study visit（Day 1 to Day 13） |
| Plasma PTH concentrations | At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17） |
| Plasma calcium concentrations | At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17） |
Countries
China
Contacts
Primary ContactXiaoyan Wen, MA
Outcome results
None listed