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RecruitingNCT06664125Updated Feb 3, 2025

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

A Phase 2 interventional study of JMKX003002 will be administered orally and Sevelamer carbonate in Hyperphosphatemia, sponsored by Jemincare. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Jemincare · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

  • Hyperphosphatemia

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03

In context

Hyperphosphatemia

173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.

This study's planned enrollment of 50 is below the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Jemincare is the lead sponsor of 37 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to understand the procedures of this trial and provide written 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    JMKX003002 once daily

    JMKX003002 once daily for 4 weeks

    Drug: JMKX003002 will be administered orally

  • Experimental
    JMKX003002 twice daily

    JMKX003002 twice daily for 4 weeks

    Drug: JMKX003002 will be administered orally

  • Active comparator
    Sevelamer carbonate

    Sevelamer carbonate three times daily for 4 weeks

    Drug: Sevelamer carbonate

Interventions

  • DrugJMKX003002 will be administered orally

    tablets for oral administration.

  • tablets for oral administration.

06

What researchers measure

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

    Time frame: 4 weeks

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Jun 2025, 6 months after the start.

Of 13 phase 2 interventional studies under Hyperphosphatemia, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 10. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2024
First posted
Oct 29, 2024
StartActual
Dec 30, 2024
Primary completionEst.
Jun 30, 2025
CompletionEst.
Sep 30, 2025
Last update
Feb 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06664125
Lead sponsor
Jemincare
Responsible party
Sponsor
First posted
Oct 29, 2024
Start date
Dec 30, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Feb 3, 2025

Study contacts

Jing Xu
Contact
xujing2@jemincare.com
0086-020-87755766
Wei Chen
Contact
0086-020-87755766

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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