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NCT06664125 | NOT YET RECRUITING | Hyperphosphatemia

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

Condition or disease

Hyperphosphatemia

Intervention/treatment

JMKX003002 will be administered orally

Sevelamer carbonate

Phase

PHASE2

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-12-30
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Location Details

NCT06664125

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Guangdong

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China,