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

Jemincare

Status and phase: Enrolling; Phase 2

Conditions: Hyperphosphatemia

Treatments: Drug: Sevelamer carbonate; Drug: JMKX003002 will be administered orally

Study type: Interventional

Funder types: Industry

Identifiers

NCT06664125

JMKX3002-H201

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

JMKX003002 once daily

Experimental group

Description:

JMKX003002 once daily for 4 weeks

Treatment:

Drug: JMKX003002 will be administered orally

JMKX003002 twice daily

Experimental group

Description:

JMKX003002 twice daily for 4 weeks

Treatment:

Drug: JMKX003002 will be administered orally

Sevelamer carbonate

Active Comparator group

Description:

Sevelamer carbonate three times daily for 4 weeks

Treatment:

Drug: Sevelamer carbonate