Actively Recruiting
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Led by Jemincare · Updated on 2025-02-03
50
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the efficacy and safety of a drug called JMKX003002 in patients with end-stage renal disease (ESRD) who are on hemodialysis and have hyperphosphatemia, which means elevated phosphate levels in the blood. It is a Phase 2a, multicenter, randomized, open-label study comparing JMKX003002 to an active drug called Sevelamer carbonate. The study is sponsored by Jemincare and aims to evaluate how well JMKX003002 lowers serum phosphorus levels over four weeks. Participants will be randomly assigned to one of three groups: one receiving JMKX003002 once daily, another receiving JMKX003002 twice daily, and a third group receiving Sevelamer carbonate three times daily. All treatments are given as oral tablets for a duration of four weeks. The study does not use blinding, so participants and researchers know which treatment is given. During the study, participants will undergo assessments focused on measuring serum phosphorus levels to evaluate the drug's effectiveness. The main outcome is the change in serum phosphorus after four weeks of treatment. Participants must be on stable hemodialysis schedules before enrollment and will be monitored for safety and treatment adherence throughout the study period, which starts in late 2024 and ends in September 2025.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the trial procedures and provide written informed consent voluntarily
- Age 18 years or older, male or female
- On a stable hemodialysis regimen two or three times per week for at least 12 weeks prior to screening
- Serum phosphorus within the trial-required range
You will not qualify if you...
- Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome
- Pregnant or breastfeeding
- Any history of parathyroid intervention
- Diarrhea or loose stools within 1 week prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive JMKX003002 or Sevelamer carbonate tablets orally to treat hyperphosphatemia while on hemodialysis.
Daily medication with oral tablets for 4 weeks
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
2
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jing Xu
W
Wei Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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