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

NCT ID: NCT06664125

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2025-09-30

Brief Summary

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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

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

Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JMKX003002 once daily

JMKX003002 once daily for 4 weeks

Group Type EXPERIMENTAL

JMKX003002 will be administered orally

Intervention Type DRUG

tablets for oral administration.

JMKX003002 twice daily

JMKX003002 twice daily for 4 weeks

Group Type EXPERIMENTAL

JMKX003002 will be administered orally

Intervention Type DRUG

tablets for oral administration.

Sevelamer carbonate

Sevelamer carbonate three times daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Sevelamer carbonate

Intervention Type DRUG

tablets for oral administration.

Interventions

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JMKX003002 will be administered orally

tablets for oral administration.

Intervention Type DRUG

Sevelamer carbonate

tablets for oral administration.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jemincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Xu

Role: CONTACT

0086-020-87755766

Wei Chen

Role: CONTACT

0086-020-87755766

Facility Contacts

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Jing Xu

Role: primary

0086-020-87755766

Other Identifiers

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JMKX3002-H201

Identifier Type: -

Identifier Source: org_study_id

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