A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Clinical Trial to Investigate the Efficacy and Safety of WS016 in the Patients With Hyperkalemia
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged ≥18 years old, male or female;
• The average blood potassium value measured by i-STAT for 2 consecutive times at screening is \>5.0 mmol/L and ≤6.5 mmol/L (with an interval of 60±10 minutes between the 2 measurements);
• Participants must provide informed consent for this trial, be able to maintain good communication with the investigator and comply with various requirements of the clinical trial (planned visits, laboratory tests, and other trial procedures, etc.).
Locations
Other Locations
China
The Affiliated Hospital of Hebei University
RECRUITING
Baoding
Peking University People's Hospital
RECRUITING
Beijing
Peking University Shougang Hospital
RECRUITING
Beijing
Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
The First People's Hospital of Tancheng County
RECRUITING
Linyi
Sir Run Run Hospital, Nanjing Medical University
RECRUITING
Nanjing
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
The Affiliated Hospital of Nantong University
RECRUITING
Nantong
The First People's Hospital of Nanyang City
RECRUITING
Nanyang
Puyang Oilfield General Hospital
RECRUITING
Puyang
Qilu Hospital of Shandong University (Qingdao)
RECRUITING
Qingdao
The First Hospital of Qiqihar
RECRUITING
Qiqihar
Minhang District Central Hospital
RECRUITING
Shanghai
Shanghai First People's Hospital
RECRUITING
Shanghai
Shanghai No.5 Hospital
RECRUITING
Shanghai
Shanghai Tongji Hospital
RECRUITING
Shanghai
Shenyang Central Hospital, affiliated to Shenyang Medical College
RECRUITING
Shenyang
Hebei Traditional Chinese Medicine Hospital
RECRUITING
Shijiazhuang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shiyan Taihe Hospital
RECRUITING
Shiyan
The Second Affiliated Hospital of Tianjin Medical University