NCT04440696

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

To Evaluate the Tolerance, pd, and pk of Lanthanum Polystyrene-sulfonate Powder in a Phase Ib/ IIa Clinical Trial in Patients With ESRD-HD Hyperphosphatemia With Multi-center, Multi-dose, Give the Drug Multiple Time

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Grand Life Science (Liaoning) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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；

Timeline

• Start date: 2020-10-21
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2020-06-22
• Last updated: 2021-07-28

Locations

1 site across 1 country: China