The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
NCT02747979 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2016-04-26
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. 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.
Conditions
- Hyperparathyroidism
- Refractory Pruritus
- Ostalgia
- Insomnia
Interventions
- OTHER
-
hemodialysis only
hemodialysis treatment only
- OTHER
-
hemodialysis plus hemoperfusion(HA330)
combination of hemodialysis and hemoperfusion (HA330) treatment
- OTHER
-
hemodialysis plus hemoperfusion(HA130)
combination of hemodialysis and hemoperfusion (HA130) treatment
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Xueqing Yu, MD · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
-
Zhihua Zheng, MD · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
-
Xunhua Zheng, master · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2010-05-31
- Completion
- 2010-05-31
Countries
- China
Study Locations
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