Overview

To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Grand Life Science (Liaoning) Co., Ltd.
Liaoning Grand Nuokang Biopharmaceutical Co., Ltd.
Collaborators:
First Hospital of Jilin University
The First Hospital of Jilin University
Treatments:
Polystyrene sulfonic acid
Criteria
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 exclusion criteria is satisfied, it is excluded):

- 1) A history of clinically significant drug allergy or atopic allergic disease
(asthma, urticaria, eczema dermatitis) or known allergy to the experimental drug or
similar drug;

- 2) Patients who had severe trauma or had undergone major surgery within 6 months prior
to the trial, or who planned to undergo surgery during the study period were screened;

- 3) Blood loss > 450mL in the three months before screening;

- 4) Clinical, radiological or laboratory evidence of active tuberculosis (TB);

- 5) Previous kidney transplantation operations;

- 6) A history of drug use and/or alcohol abuse in the 3 months prior to screening (14
units of alcohol consumed per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL
wine);

- 7) Those who were receiving any vitamin D or calcium-like regimens at the time of
screening and could not maintain a stable dose after admission (except those who were
receiving a stable vitamin D or calcium-like regimens);

- 8) Have dysphagia or gastrointestinal history with any influence on drug absorption,
including but not limited to intestinal obstruction, macrocolon, habitual constipation
(stool frequency < 1 times per week), chronic diarrhea (stool frequency ≥4 times per
day), gastroparesis with nausea or vomiting and other gastrointestinal disorders and
gastrointestinal surgery;

- 9) suffer from any disease that increases the risk of gastrointestinal bleeding, such
as acute erosive gastritis, acute hemorrhagic necrotizing enteritis, or active
gastrointestinal ulcer;

- 10) For poorly controlled hypertension, the systolic blood pressure ≥180 mmHg and/or
diastolic blood pressure ≥110 mmHg should be measured at rest, and the patient should
be rechecked at most twice for confirmation;

- 11) The history of acute coronary syndrome (such as myocardial infarction, unstable
angina pectoris hospitalization), or percutaneous coronary intervention, or coronary
artery bypass grafting in the previous 12 months was screened;Or had an
arterial/venous thrombosis event, such as a cerebrovascular accident (including a
history of stroke or transient ischemic attack), deep venous thrombosis and pulmonary
embolism, within 12 months before screening;

- 12) Uncontrolled severe arrhythmias, such as recurrent and highly symptomatic
ventricular tachycardia, atrial fibrillation with rapid ventricular response, or
supraventricular tachycardia, that were not controlled by medication or other
treatment in the 12 months prior to enrolment;

- 13) Unstable and serious diseases of the digestive system, respiratory system, mental
nervous system, endocrine system, blood system, malignant tumor, etc., which are not
suitable for the study as judged by the study doctor;

- 14) Screening patients with a history of acute or severe infection within the previous
1 month;

- 15) Take phosphorus-reducing drugs, such as lanthanum carbonate, calcium carbonate,
calcium acetate, aluminum hydroxide, Sveram, etc., within 14 days before
administration;Drugs that may affect lanthanum ion release, such as proton pump
inhibitors, H2 receptor antagonists, etc.And drugs that interact with experimental
drugs, such as ciprofloxacin hydrochloride, thyroxine, lithium, etc.;Drugs containing
phosphoric acid components, such as oseltamivir phosphate, sitagliptin phosphate
tablets, etc.

- 16) Those who have participated in any clinical trials of drugs or medical devices
within one month before taking the study drug;

- 17) During screening, hemoglobin ≤90g/L and albumin ≤30g/L;

- 18) Hypercalcemia, blood calcium ≥2.52mmol/L;Hypocalcemia, blood calcium ≤1.80mmol/L
(corrected blood calcium value: corrected blood calcium value mmol/L= measured calcium
value mmol/L+0.02× (40g/L- measured serum albumin value g/L));

- 19) Severe hyperparathyroidism, parathyroid hormone (PTH) >1200pg/mL;

- 20) Female subjects with positive blood pregnancy results during the screening period
or baseline period;

- 21) HIV antigen/antibody positive;Positive antibody to Treponema pallidum and positive
serological test of non-Treponema pallidum (such as rapid plasma reaction test,
toluidine red unheated serum test, etc.);

- 22) A history of heart failure as defined by the New York College of Cardiology (NYHA)
as III-IV, or a left ventricular ejection fraction less than 40%;

- 23) Subjects who have other factors considered by the investigator to be unsuitable
for participating in this study.