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

NCT04440696 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-28

No results posted yet for this study

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

Interventions

DRUG

Lanthanum Polystyrene Sulphonate Powder

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

DRUG

Lanthanum Carbonate 500 MG

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

DRUG

Placebo

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

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Grand Life Science (Liaoning) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, Ph.D · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440696 on ClinicalTrials.gov