Systemic Lupus
Conditions
Keywords
hemodiafiltration with endogenous re infusion, immune adsorption In Lupus nephritis
Brief 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
Detailed 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.
Interventions
PROCEDUREhemodiafiltration with endogenous re infusion (HFR)
hemodiafiltration with endogenous re infusion (HFR) for cases 2
Sponsors
Dr. Mohamed Ahmed El ghiriani
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients will not be masked as hemodiafiltration with endogenous re infusion must be observed
Intervention model description
Role of online hemodiafiltration with endogenous re infusion in treatment of systemic lupus erythematosus activity resistant to conventional therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* systemic lupus erythematosus in activity
Exclusion criteria
* End stage renal disease, other renal replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement In signs and symptoms of lupus activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | 12 months | For cases group |
Countries
Egypt
Outcome results
None listed