HyperparathyroidismPhase 2/3NCT02747979
The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
A Phase 2/3 study testing hemodialysis only, hemodialysis plus hemoperfusion(HA330) and hemodialysis plus hemoperfusion(HA130) in people with Hyperparathyroidism and Refractory Pruritus, run by Sun Yat-sen University at 1 site in China.
Trial summary
A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients. There are two phases of study for each subject. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Hyperparathyroidism, Refractory Pruritus, Ostalgia
- What is being tested?
- hemodialysis only, hemodialysis plus hemoperfusion(HA330) and hemodialysis plus hemoperfusion(HA130)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to May 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willingness to sign an informed consent
- Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
- middle or large molecules retention defined as immunoreactive parathyroid hormone (iPTH) > 400 pg/mL, β2MG>5000 pg/ml、CRP>10mg/l.
- Refractory pruritus, carpal tunnel syndrome, restless leg syndrome, hyperparathyroidism or other refratory complications.
Who cannot join
- Incapable or reluctant to sign the informed consent or comply the schedule.
- platelet (PLT) count<60×109/L or disturbance in coagulation, tendency of severe bleeding or acute bleeding.
- Severe hypotension and heart or lung insufficiency
- Known hypersensitive or contradiction or intolerance to dialyzer or adsorbents
- Attend to other clinic trial now or in recent 30 days
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.
There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.
Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
Read the detailed description
All patients recruited from these centers who met the inclusion criteria were randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
Hemoperfusion is performed by HA130 or HA330 resin adsorbents. Blood flow is 200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD) incidence.
- Conditions
- Hyperparathyroidism, Refractory Pruritus, Ostalgia, Insomnia
- Being tested
- hemodialysis only, hemodialysis plus hemoperfusion(HA330), hemodialysis plus hemoperfusion(HA130)
- Keywords
- hemodialysis, hyperparathyroidism, refractory pruritus, ostalgia, insomnia, CVD incidence, life quality
- Medical subject headings
- Hyperparathyroidism, Pruritus, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysis onlyOther
hemodialysis treatment only
hemodialysis plus hemoperfusion(HA330)Other
combination of hemodialysis and hemoperfusion (HA330) treatment
hemodialysis plus hemoperfusion(HA130)Other
combination of hemodialysis and hemoperfusion (HA130) treatment
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis+hemoperfusion (HA330) | Experimental | Combination of hemodialysis and hemoperfusion (HA330) therapy All subjects in the study phase will receive hemodialysis plus hemoperfusion(HA330) treatment once per week, and regular hemodialysis treatment in the remaining two sessions. Receives: Other: hemodialysis only; Other: hemodialysis plus hemoperfusion(HA330) |
| hemodialysis+hemoperfusion (HA130) | Experimental | Combination of hemodialysis and hemoperfusion (HA130) treatment All subjects in the study phase will receive hemodialysis and hemoperfusion(HA130) treatment once per week, and regular hemodialysis treatment in the remaining two sessions. Receives: Other: hemodialysis only; Other: hemodialysis plus hemoperfusion(HA130) |
| hemodialysis only | Active comparator | hemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week. Receives: Other: hemodialysis only |
What is being measured
The primary outcome is the main question the study is designed to answer.
the longitudinal changes of itching
Measured: every week, up to 12 weeks.
Secondary outcomes (6)
the longitudinal changes of serum middle molecules of β2MG concentrations
The serum concentration of β2MG will be measured using ELISA method
Measured: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of iPTH concentrations
The serum concentration of iPTH will be measured using ELISA method
Measured: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of CRP concentrations
The serum concentration of CRP will be measured using ELISA method
Measured: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of ADMA concentrations
The serum concentration of ADMA will be measured using ELISA method
Measured: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of BMP2concentrations
The serum concentration of BMP2 will be measured using ELISA method
Measured: every week,up to 12 weeks.
the longitudinal changes of the nutritional status
The nutritional status was evaluated using the serum level of albumin, the subjective global assessment score and BMI. The serum level of albumin will measured using the blood analysis biochemical analyzer, the subjective global assessment score will measured using the SGA scale and the BMI will measured through the physical examination and calculated by weight (kg)/height2 (m2).
Measured: every week,up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, MD, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen UniversityZhihua Zheng, MD, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen UniversityXunhua Zheng, master, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747979
- Sponsor's protocol ID
- SYSU-HD+HP
- Status last verified
- Apr 2016
- First submitted
- 21 May 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Combination Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
- ClinicalTrials.gov ID
- NCT02747979
- Acronym / sponsor ID
- SYSU-HD+HP
- Conditions
- Hyperparathyroidism, Refractory Pruritus, Ostalgia, Insomnia
- Keywords
- hemodialysis, hyperparathyroidism, refractory pruritus, ostalgia, insomnia, CVD incidence, life quality
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.
There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.
Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
Detailed description
All patients recruited from these centers who met the inclusion criteria were randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.
Hemoperfusion is performed by HA130 or HA330 resin adsorbents. Blood flow is 200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD) incidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hemodialysis+hemoperfusion (HA330) | Experimental | Other: hemodialysis only, Other: hemodialysis plus hemoperfusion(HA330)Combination of hemodialysis and hemoperfusion (HA330) therapy All subjects in the study phase will receive hemodialysis plus hemoperfusion(HA330) treatment once per week, and regular hemodialysis treatment in the remaining two sessions. |
| hemodialysis+hemoperfusion (HA130) | Experimental | Other: hemodialysis only, Other: hemodialysis plus hemoperfusion(HA130)Combination of hemodialysis and hemoperfusion (HA130) treatment All subjects in the study phase will receive hemodialysis and hemoperfusion(HA130) treatment once per week, and regular hemodialysis treatment in the remaining two sessions. |
| hemodialysis only | Active comparator | Other: hemodialysis onlyhemodialysis only All subjects in the study phase will receive regular hemodialysis treatment three times per week. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to sign an informed consent
- Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
- middle or large molecules retention defined as immunoreactive parathyroid hormone (iPTH) > 400 pg/mL, β2MG>5000 pg/ml、CRP>10mg/l.
- Refractory pruritus, carpal tunnel syndrome, restless leg syndrome, hyperparathyroidism or other refratory complications.
Key exclusion criteria (5 listed)
- Incapable or reluctant to sign the informed consent or comply the schedule.
- platelet (PLT) count<60×109/L or disturbance in coagulation, tendency of severe bleeding or acute bleeding.
- Severe hypotension and heart or lung insufficiency
- Known hypersensitive or contradiction or intolerance to dialyzer or adsorbents
- Attend to other clinic trial now or in recent 30 days
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 |
|---|---|---|
| hemodialysis onlyhemodialysis treatment only | Other | hemodialysis only, hemodialysis+hemoperfusion (HA130), hemodialysis+hemoperfusion (HA330) |
| hemodialysis plus hemoperfusion(HA330)combination of hemodialysis and hemoperfusion (HA330) treatment | Other | hemodialysis+hemoperfusion (HA330) |
| hemodialysis plus hemoperfusion(HA130)combination of hemodialysis and hemoperfusion (HA130) treatment | Other | hemodialysis+hemoperfusion (HA130) |
Primary outcome
the longitudinal changes of itching
Time frame: every week, up to 12 weeks.
6 secondary outcomes
the longitudinal changes of serum middle molecules of β2MG concentrations
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of iPTH concentrations
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of CRP concentrations
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of ADMA concentrations
Time frame: every week,up to 12 weeks.
the longitudinal changes of serum middle molecules of BMP2concentrations
Time frame: every week,up to 12 weeks.
the longitudinal changes of the nutritional status
Time frame: every week,up to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
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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. This study is not recruiting at the moment.
Xueqing Yu, MD principal investigator
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Zhihua Zheng, MD principal investigator
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Xunhua Zheng, master principal investigator
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hemodialysis only, hemodialysis plus hemoperfusion(HA330) and hemodialysis plus hemoperfusion(HA130) in people with Hyperparathyroidism and Refractory Pruritus, run by Sun Yat-sen 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Apr 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the longitudinal changes of itching (time frame: every week, up to 12 weeks.). 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 NCT02747979, which also lists 1 linked publication.
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 26 Apr 2016.