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
Overview
- Phase
- Phase 2
- Intervention
- JMKX003002 will be administered orally
- Conditions
- Hyperphosphatemia
- Sponsor
- Jemincare
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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
Detailed Description
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
JMKX003002 once daily
JMKX003002 once daily for 4 weeks
Intervention: JMKX003002 will be administered orally
JMKX003002 twice daily
JMKX003002 twice daily for 4 weeks
Intervention: JMKX003002 will be administered orally
Sevelamer carbonate
Sevelamer carbonate three times daily for 4 weeks
Intervention: Sevelamer carbonate
Outcomes
Primary Outcomes
To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis
Time Frame: 4 weeks
The change in serum phosphorus (sP) level from baseline to the end of treatment