RecruitingPhase 2NCT06664125
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
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
Sponsor
Jemincare
Enrollment
50 participants
Start Date
Dec 30, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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.
Exclusion Criteria4
- Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;
- Pregnant or breastfeeding;
- Any history of a parathyroid intervention;
- Diarrhea or loose stools occurred within 1 week prior to randomization.
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Interventions
DRUGJMKX003002 will be administered orally
tablets for oral administration.
DRUGSevelamer carbonate
tablets for oral administration.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06664125
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