Immune Adsorption Role in Treatment of Resistant Lupus

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Systemic Lupus

Intervention / Treatment
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* Procedure: hemodiafiltration with endogenous re infusion (HFR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systemic lupus erythematosus in activity Exclusion Criteria: End stage renal disease, other renal replacement therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Role of online hemodiafiltration with endogenous re infusion in treatment of systemic lupus erythematosus activity resistant to conventional therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: systemic lupus in activity<br>Sixty systemic lupus patients in activity will receive conventional therapy (47 patient as cases 1) and immunadsortion (13 patients as cases 2) will be provided to the non responders | Procedure: hemodiafiltration with endogenous re infusion (HFR)<br>* hemodiafiltration with endogenous re infusion (HFR) for cases 2<br>* Other names: Measurement of C1q levels;|
| Other: Control group 30 subjects<br>controls 1 (20 healthy volunteers, controls 2 (10 patients with glomerular diseases other than lupus) will do routine laboratory investigations | Procedure: hemodiafiltration with endogenous re infusion (HFR)<br>* hemodiafiltration with endogenous re infusion (HFR) for cases 2<br>* Other names: Measurement of C1q levels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement In signs and symptoms of lupus activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | For cases group | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodiafiltration with endogenous re infusion, immune adsorption In Lupus nephritis