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

Launched by JEMINCARE · Oct 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JMKX003002 for patients with end-stage renal disease (ESRD) who are on hemodialysis and have high levels of phosphorus in their blood, a condition known as hyperphosphatemia. The goal is to see how effective and safe this treatment is for managing their phosphorus levels. The trial is currently recruiting participants who are at least 18 years old, have been on a stable hemodialysis routine for at least 12 weeks, and have phosphorus levels within the required range.

Eligible participants can expect to be part of a study where they will receive either the new medication or a standard treatment. They will need to provide informed consent and attend regular check-ups to monitor their health during the trial. It's important to note that individuals with certain medical conditions, such as inflammatory bowel disease or those who are pregnant or breastfeeding, will not be able to participate. This trial aims to improve treatment options for people with high phosphorus levels, which can be a serious issue for patients with kidney disease.

Gender

ALL

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.