BridgeMD
New treatment option for Uremia
Official title Multi-center Clinical Study on Hemoperfusion of KHA80
ClinicalTrials.gov ID: NCT06233838
What this study is testing
- What it's testing
- To evaluate the decreasing rate of blood IL-6, β2-MG and PTH in maintenance hemodialysis patients in the 52nd week compared with routine hemodialysis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old, regardless of sex;
- According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));
- receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;
- blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;
- Sign the informed consent form.
You likely can't join if
- Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors;
- Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L;
- Hemodialysis blood flow \< 200 ml/min.
- Kt/V\<1.2；
- Serum albumin \< 30g/L;
- Parathyroid resection within one year;
See the full eligibility criteria
- Age ≥18 years old, regardless of sex;
- According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));
- receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;
- blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;
- Sign the informed consent form.
- Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors;
- Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L;
- Hemodialysis blood flow \< 200 ml/min.
- Kt/V\<1.2；
- Serum albumin \< 30g/L;
- Parathyroid resection within one year;
- people with low blood pressure and severe cardiopulmonary insufficiency;
- lactating or pregnant women or those who plan to be pregnant within one year;
- infection, history of malignant tumor, active stage of rheumatic immune disease;
- Patients whose life expectancy is less than one year;
- Other clinical researchers are currently or recently (within 30 days);
- According to the researcher's judgment, the patient has other unsuitable conditions.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.