A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Able to understand the procedures of this trial and provide written informed consent voluntarily;
• Age ≥ 18 years, male or female;
• On a stable hemodialysis regimen at a frequency of two or three times per week for at least 12 weeks prior to the screening visit;
• Serum phosphorus within the trial-required range.
Locations
Other Locations
China
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Contact Information
Primary
Jing Xu
xujing2@jemincare.com
0086-020-87755766
Backup
Wei Chen
0086-020-87755766
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 50
Treatments
Experimental: JMKX003002 once daily
JMKX003002 once daily for 4 weeks
Experimental: JMKX003002 twice daily
JMKX003002 twice daily for 4 weeks
Active_comparator: Sevelamer carbonate
Sevelamer carbonate three times daily for 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Jemincare