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

ConditionHyperphosphatemia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorJemincare

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand the procedures of this trial and provide written informed consent voluntarily;

Age ≥ 18 years, male or female;

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;

Serum phosphorus within the trial-required range.

Disqualifiers

Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;

Pregnant or breastfeeding;

Any history of a parathyroid intervention;

Diarrhea or loose stools occurred within 1 week prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

JMKX003002 will be administered orally
Drug
tablets for oral administration.
Sevelamer carbonate
Drug
tablets for oral administration.

Treatment groups

50 Participants

are divided into 3 treatment groups

Group A: JMKX003002 once dailyExperimental treatment 1 intervention

Group B: JMKX003002 twice dailyExperimental treatment 1 intervention

Group C: Sevelamer carbonateActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov

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