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

NCT04440696 | Unknown Phase 1

• 1 other identifier: JBL-2019-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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）

Study Arms (4)

group 1:dose 1.5g

EXPERIMENTAL

There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）

Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo

group 2:dose 3g

EXPERIMENTAL

There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）

Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo

group 3:dose 4.5g

EXPERIMENTAL

There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）

Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo

group 4:dose 6g

EXPERIMENTAL

There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）

Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo

Interventions

Lanthanum Polystyrene Sulphonate Powder DRUG

D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；

group 1:dose 1.5g; group 2:dose 3g; group 3:dose 4.5g; group 4:dose 6g

Lanthanum Carbonate 500 MG DRUG

D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；

group 1:dose 1.5g; group 2:dose 3g; group 3:dose 4.5g; group 4:dose 6g

Placebo DRUG

D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；

group 1:dose 1.5g; group 2:dose 3g; group 3:dose 4.5g; group 4:dose 6g

Eligibility Criteria

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

You may qualify if:

• \) Sign the informed consent before the trial, and fully understand the test content, process and possible adverse reactions;
• \) Able to complete the study according to the requirements of the experimental program, able to accept dietary management and unified diet during the trial;
• \) 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;
• \) 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);
• \) 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;
• \) 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);
• \) In patients with end-stage renal disease hyperphosphatemia, fasting blood phosphorus ≥1.78mmol/L and ≤3.23mmol/L were measured at screening and admission.

You may not qualify if:

• \) 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;
• \) 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;
• \) Blood loss \> 450mL in the three months before screening;
• \) Clinical, radiological or laboratory evidence of active tuberculosis (TB);
• \) Previous kidney transplantation operations;
• \) 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);
• \) 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);
• \) 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;
• \) suffer from any disease that increases the risk of gastrointestinal bleeding, such as acute erosive gastritis, acute hemorrhagic necrotizing enteritis, or active gastrointestinal ulcer;
• \) 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;
• \) 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;
• \) 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;
• \) 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;
• \) Screening patients with a history of acute or severe infection within the previous 1 month;
• \) 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.

Sponsors & Collaborators

• Grand Life Science (Liaoning) Co., Ltd.: lead
• The First Hospital of Jilin University: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yanhua Ding, Ph.D

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wen, MA

CONTACT

+86 18704019565; wenxiaoyan@nkbp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: October 21, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)