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
1 other identifier
interventional
50
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2024
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedStudy Start
First participant enrolled
December 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedFebruary 3, 2025
October 1, 2024
6 months
October 27, 2024
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis
The change in serum phosphorus (sP) level from baseline to the end of treatment
4 weeks
Study Arms (3)
JMKX003002 once daily
EXPERIMENTALJMKX003002 once daily for 4 weeks
JMKX003002 twice daily
EXPERIMENTALJMKX003002 twice daily for 4 weeks
Sevelamer carbonate
ACTIVE COMPARATORSevelamer carbonate three times daily for 4 weeks
Interventions
tablets for oral administration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jemincarelead
Study Sites (2)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2024
First Posted
October 29, 2024
Study Start
December 30, 2024
Primary Completion
June 30, 2025
Study Completion
September 30, 2025
Last Updated
February 3, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share