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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| systemic lupus in activity | Experimental | 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 |
|
| Control group 30 subjects | Other | controls 1 (20 healthy volunteers, controls 2 (10 patients with glomerular diseases other than lupus) will do routine laboratory investigations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemodiafiltration with endogenous re infusion (HFR) | Procedure | hemodiafiltration with endogenous re infusion (HFR) for cases 2 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naga S Salah, Professor | University of Alexandria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Alexandria University | Alexandria | Sidi Beshr | 21624 | Egypt |
data will be available and can be shared
2 days, forever available
no specific criteria
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| ID | Term |
|---|---|
| D017583 | Hemodiafiltration |
| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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Role of online hemodiafiltration with endogenous re infusion in treatment of systemic lupus erythematosus activity resistant to conventional therapy
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Patients will not be masked as hemodiafiltration with endogenous re infusion must be observed
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|
| D006440 |
| Hemofiltration |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |