Evaluating a new treatment for high phosphorus levels in kidney disease patients on dialysis

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

This study is testing a new treatment for high phosphorus levels in adults with kidney disease on dialysis to see if it works better than a current medication.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06664125 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial aims to assess the efficacy and safety of JMKX003002 in patients with end-stage renal disease who are undergoing hemodialysis and have hyperphosphatemia. The study is multicenter, randomized, and open-label, comparing the new treatment to an active control, Sevelamer carbonate. Participants will be monitored for their response to the treatment, focusing on changes in serum phosphorus levels and overall safety. The trial will include adults who have been on a stable hemodialysis regimen for at least 12 weeks prior to screening.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with end-stage renal disease on stable hemodialysis and elevated serum phosphorus levels.

Not a fit: Patients with a history of inflammatory bowel disease, diarrhea, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve phosphorus control in patients with end-stage renal disease, potentially enhancing their overall health and quality of life.

How similar studies have performed: Other studies have explored treatments for hyperphosphatemia in dialysis patients, but the specific approach of JMKX003002 is novel.

Eligibility 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.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jing Xu

Conditions Hyperphosphatemia