Immune Adsorption Role in Treatment of Resistant Lupus

Systemic Lupus Clinical Trial

— HFR  

Official title:

Role of Online Hemodiafiltration With Endogenous Reinfusion in Treatment of Systemic Lupus Erythematosus Activity Resistant to Conventional Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108611
• Other study ID #: PhD MElghiriani
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 25, 2019

Study information

• Verified date: September 2019
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: lupus is a heterogeneous autoimmune disease with autoantibodies formation. Lupus nephritis carries the worst prognosis. C1q deficiency correlates with activity and renal involvement and may help in its evaluation. Therapies include plasma exchange, immune adsorption and recently under evaluation, hemodiafiltration with on-line endogenous re infusion (HFR), in addition to traditional immunosuppressive therapies. Aim: is to evaluate the role of HFR in improving signs and symptoms of SLE activity and laboratory parameters not responding to traditional immune suppressive therapy

Description:

Settings and design: A controlled clinical study was conducted on group A, sixty patients with lupus in activity subdivided into cases 1, 47 patients, who received traditional medical treatment and cases 2 group, 13 patients, who underwent HFR in addition to medical treatment. And group B that consisted of two subgroups, control 1, 20 healthy age and sex matched volunteers and control 2, 10 cases with different glomerular diseases other than lupus.

Methods and materials: Serum c1q was done before and after the HFR as well as induction by medical treatment. Disease activity assessed using SLEDAI-2K with responder index - 50, quality of life assessed using SLEQOL v2, and HFR was performed for the non-responder group.

The study will be conducted in Alexandria University Hospitals in compliance with the Declaration of Helsinki; the ethical committee of the investigator's faculty will be requested to approve the protocol and the patients will be requested to give informed consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 25, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• systemic lupus erythematosus in activity

Exclusion Criteria:

• End stage renal disease, other renal replacement therapy

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus

Intervention

Procedure:
• hemodiafiltration with endogenous re infusion (HFR)
hemodiafiltration with endogenous re infusion (HFR) for cases 2

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Alexandria University	Alexandria	Sidi Beshr

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Mohamed Ahmed El ghiriani

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement In signs and symptoms of lupus activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	For cases group	12 months