Multi-center Clinical Study on Hemoperfusion of KHA80

Launched by FIRST AFFILIATED HOSPITAL OF FUJIAN MEDICAL UNIVERSITY · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called hemoperfusion with a substance known as KHA80 for patients with certain kidney problems, specifically those who are undergoing regular hemodialysis. The main goal is to see if this treatment can help lower levels of certain substances in the blood, including IL-6, β2-MG, and PTH, after 52 weeks compared to standard hemodialysis. These substances can be higher in patients with conditions like uremia, uremic osteodystrophy, and complications related to dialysis.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with advanced kidney disease (CKD5) that requires regular hemodialysis for at least three months. They should have specific levels of β2-MG, PTH, or IL-6 in their blood. However, the trial excludes patients with certain health issues, such as severe bleeding problems, recent major surgeries, or other serious medical conditions. Participants can expect to receive either the new treatment or standard care while being monitored closely by the research team throughout the study. This trial is currently recruiting participants, and those interested will need to provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old, regardless of sex;
• • 2. According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));
• • 3. receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;
• • 4. blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;
• • 5. Sign the informed consent form.
• Exclusion Criteria:
• • 1. Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors;
• • 2. Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L;
• • 3. Hemodialysis blood flow \< 200 ml/min.
• • 4. Kt/V\<1.2；
• • 5. Serum albumin \< 30g/L;
• • 6. Parathyroid resection within one year;
• • 7. people with low blood pressure and severe cardiopulmonary insufficiency;
• • 8. lactating or pregnant women or those who plan to be pregnant within one year;
• • 9. infection, history of malignant tumor, active stage of rheumatic immune disease;
• • 10. Patients whose life expectancy is less than one year;
• • 11. Other clinical researchers are currently or recently (within 30 days);
• • 12. According to the researcher's judgment, the patient has other unsuitable conditions.