drugset / Trial / NCT04440696
To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder
Phase 1/2
Unknown
48 enrolled
Grand Life Science (Liaoning) Co., Ltd.
The First Hospital of Jilin University · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2020-10-21
- Primary completion
- 2022-06-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lanthanum Polystyrene Sulphonate | Unknown | 1.5 g | — |
| Subject | Lanthanum Polystyrene Sulphonate | Unknown | 3 g | — |
| Subject | Lanthanum Polystyrene Sulphonate | Unknown | 4.5 g | — |
| Subject | Lanthanum Polystyrene Sulphonate | Unknown | 6 g | — |
| Background | Lanthanum Carbonate | Other / unclassified | 500 mg | — |