Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Phase 2

Recruiting

• Conditions: Hyperphosphatemia
• Interventions: Drug: JMKX003002 will be administered orally; Drug: Sevelamer carbonate

• Registration Number: NCT06664125
• Lead Sponsor: Jemincare

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

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Study First Posted: 2024-10-29
• Study Start: 2024-12-30
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Able to understand the procedures of this trial and provide written informed consent voluntarily;
2. Age ≥ 18 years, male or female;
3. 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;
4. Serum phosphorus within the trial-required range.

Exclusion Criteria

1. Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;
2. Pregnant or breastfeeding;
3. Any history of a parathyroid intervention;
4. Diarrhea or loose stools occurred within 1 week prior to randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JMKX003002 once daily	JMKX003002 will be administered orally	JMKX003002 once daily for 4 weeks
JMKX003002 twice daily	JMKX003002 will be administered orally	JMKX003002 twice daily for 4 weeks
Sevelamer carbonate	Sevelamer carbonate	Sevelamer carbonate three times daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis	4 weeks	The change in serum phosphorus (sP) level from baseline to the end of treatment

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China