The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients

NCT02747979 | Completed Phase 2 DMC

• 1 other identifier: SYSU-HD+HP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hemodialysis; hyperparathyroidism; refractory pruritus; ostalgia; insomnia; CVD incidence; life quality

Outcome Measures

Primary Outcomes (1)

• the longitudinal changes of itching

  every week, up to 12 weeks.

Secondary Outcomes (6)

• the longitudinal changes of serum middle molecules of β2MG concentrations

  every week,up to 12 weeks.

• the longitudinal changes of serum middle molecules of iPTH concentrations

  every week,up to 12 weeks.

• the longitudinal changes of serum middle molecules of CRP concentrations

  every week,up to 12 weeks.

• the longitudinal changes of serum middle molecules of ADMA concentrations

  every week,up to 12 weeks.

• the longitudinal changes of serum middle molecules of BMP2concentrations

  every week,up to 12 weeks.

Study Arms (3)

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.

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.

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.

Other: hemodialysis only

Interventions

hemodialysis only OTHER

hemodialysis treatment only

hemodialysis only; hemodialysis+hemoperfusion (HA130); hemodialysis+hemoperfusion (HA330)

hemodialysis plus hemoperfusion(HA330) OTHER

combination of hemodialysis and hemoperfusion (HA330) treatment

hemodialysis+hemoperfusion (HA330)

hemodialysis plus hemoperfusion(HA130) OTHER

combination of hemodialysis and hemoperfusion (HA130) treatment

hemodialysis+hemoperfusion (HA130)

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 33283264 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism; Pruritus; Sleep Initiation and Maintenance Disorders

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Xueqing Yu, MD

  Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Zhihua Zheng, MD

  Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Xunhua Zheng, master

  Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: April 22, 2016
• Study Start: April 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

CN (1)