Clinical Trials Directory

Trials / Completed

CompletedNCT04108611

Immune Adsorption Role in Treatment of Resistant Lupus

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Dr. Mohamed Ahmed El ghiriani · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREhemodiafiltration with endogenous re infusion (HFR)hemodiafiltration with endogenous re infusion (HFR) for cases 2

Timeline

Start date
2019-01-01
Primary completion
2019-05-01
Completion
2019-09-25
First posted
2019-09-30
Last updated
2019-10-01

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04108611. Inclusion in this directory is not an endorsement.