UremiaNCT06233838
Multi-center Clinical Study on Hemoperfusion of KHA80
A study testing KHA80 hemoperfusion treatment in people with Uremia and Uremic Osteodystrophy, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremia, Uremic Osteodystrophy, Dialysis Related Complication
- What is being tested?
- KHA80 hemoperfusion treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
Jianxin Wan, doctor, 13805052715, wanjx@fjmu.edu.cn
Yi Chen, doctor, 13600827047, chinaalec@126.com
About this study
Official title: Prospective, Multicenter, Randomized, Open Label Study on the Efficacy and Safety of Comparison of KHA80 Blood Perfusion Combined With Hemodialysis and Conventional Hemodialysis in Clearing IL-6, β2-MG and PTH in Maintenance Hemodialysis Patients
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.
Read the detailed description
394 patients with maintenance hemodialysis were included in the study, and the blood purification time was ≥8 hours per week (including routine hemodialysis, high-throughput hemodialysis, hemodialysis filtration, hemoperfusion, etc.). Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week; The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. The follow-up data of 0, 4, 12, 24, 36 and 52 weeks of treatment in the two groups were collected, and the information of combined medication and adverse events was also collected.
- Conditions
- Uremia, Uremic Osteodystrophy, Dialysis Related Complication
- Being tested
- KHA80 hemoperfusion treatment
- Keywords
- KHA80, Maintenance hemodialysis, IL-6, β2-MG, PTH
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHA80 hemoperfusion treatmentDevice
On the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month.
| Study group | Role | What they receive |
|---|---|---|
| KHA80 hemoperfusion treatment | Experimental | The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. Receives: Device: KHA80 hemoperfusion treatment |
| Routine hemodialysis | No intervention | Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of change of IL-6, β2-MG and PTH
the rate of change of IL-6, β2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis.
Measured: in the 52nd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start13 Jan 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for UremiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wanjianxin, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233838
- Sponsor's protocol ID
- 8339-001
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen SJ, Jiang GR, Shan JP, Lu W, Huang HD, Ji G, Wu P, Wu GF, Wang W, Zhu C, Bian F. Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidney. Int J Artif Organs. 2011 Apr;34(4):339-47. doi: 10.5301/IJAO.2011.7748.
PubMed 21534244Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-1557. doi: 10.1681/ASN.V1271549.
PubMed 11423586Rao M, Guo D, Perianayagam MC, Tighiouart H, Jaber BL, Pereira BJ, Balakrishnan VS. Plasma interleukin-6 predicts cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2005 Feb;45(2):324-33. doi: 10.1053/j.ajkd.2004.09.018.
PubMed 15685511Thang LV, Loc ND, Dung NH, Kien NT, Quyen DBQ, Tuan NM, Ha DM, Kien TQ, Dung NTT, Van DT, Van Duc N, Ha NTT, Toan PQ, Usui T, Nangaku M. Predicting 3-year mortality based on the tumor necrosis factor alpha concentration in low-flux hemodialysis patients. Ther Apher Dial. 2020 Oct;24(5):554-560. doi: 10.1111/1744-9987.13463. Epub 2020 Jan 27.
PubMed 31856402
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Open Label Study on the Efficacy and Safety of Comparison of KHA80 Blood Perfusion Combined With Hemodialysis and Conventional Hemodialysis in Clearing IL-6, β2-MG and PTH in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06233838
- Acronym / sponsor ID
- 8339-001
- Conditions
- Uremia, Uremic Osteodystrophy, Dialysis Related Complication
- Keywords
- KHA80, Maintenance hemodialysis, IL-6, β2-MG, PTH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
394 patients with maintenance hemodialysis were included in the study, and the blood purification time was ≥8 hours per week (including routine hemodialysis, high-throughput hemodialysis, hemodialysis filtration, hemoperfusion, etc.). Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week; The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. The follow-up data of 0, 4, 12, 24, 36 and 52 weeks of treatment in the two groups were collected, and the information of combined medication and adverse events was also collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHA80 hemoperfusion treatment | Experimental | Device: KHA80 hemoperfusion treatmentThe experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. |
| Routine hemodialysis | No intervention | –Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHA80 hemoperfusion treatmentOn the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month. | Device | KHA80 hemoperfusion treatment |
Primary outcome
the rate of change of IL-6, β2-MG and PTH
Time frame: in the 52nd week
the rate of change of IL-6, β2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 21534244Chen SJ, Jiang GR, Shan JP, Lu W, Huang HD, Ji G, Wu P, Wu GF, Wang W, Zhu C, Bian F. Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidney. Int J Artif Organs. 2011 Apr;34(4):339-47. doi: 10.5301/IJAO.2011.7748.
- Background: PubMed 11423586Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-1557. doi: 10.1681/ASN.V1271549.
- Background: PubMed 15685511Rao M, Guo D, Perianayagam MC, Tighiouart H, Jaber BL, Pereira BJ, Balakrishnan VS. Plasma interleukin-6 predicts cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2005 Feb;45(2):324-33. doi: 10.1053/j.ajkd.2004.09.018.
- Background: PubMed 31856402Thang LV, Loc ND, Dung NH, Kien NT, Quyen DBQ, Tuan NM, Ha DM, Kien TQ, Dung NTT, Van DT, Van Duc N, Ha NTT, Toan PQ, Usui T, Nangaku M. Predicting 3-year mortality based on the tumor necrosis factor alpha concentration in low-flux hemodialysis patients. Ther Apher Dial. 2020 Oct;24(5):554-560. doi: 10.1111/1744-9987.13463. Epub 2020 Jan 27.
- Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidneyLink provided by the sponsor.
- The microinflammatory state in uremia: causes and potential consequences.Link provided by the sponsor.
- Plasma interleukin-6 predicts cardiovascular mortality in hemodialysis patientsLink provided by the sponsor.
- Predicting 3-year mortality based on the tumor necrosis factor alpha concentration in low-flux hemodialysis patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KHA80 hemoperfusion treatment in people with Uremia and Uremic Osteodystrophy, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of change of IL-6, β2-MG and PTH (time frame: in the 52nd week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06233838, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.