Immune Adsorption Role in Treatment of Resistant Lupus

NCT ID: NCT04108611

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-09-25

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.

Conditions

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Systemic Lupus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Role of online hemodiafiltration with endogenous re infusion in treatment of systemic lupus erythematosus activity resistant to conventional therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Patients will not be masked as hemodiafiltration with endogenous re infusion must be observed

Study Groups

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systemic lupus in activity

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

Group Type EXPERIMENTAL

hemodiafiltration with endogenous re infusion (HFR)

Intervention Type PROCEDURE

hemodiafiltration with endogenous re infusion (HFR) for cases 2

Control group 30 subjects

controls 1 (20 healthy volunteers, controls 2 (10 patients with glomerular diseases other than lupus) will do routine laboratory investigations

Group Type OTHER

hemodiafiltration with endogenous re infusion (HFR)

Intervention Type PROCEDURE

hemodiafiltration with endogenous re infusion (HFR) for cases 2

Interventions

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hemodiafiltration with endogenous re infusion (HFR)

hemodiafiltration with endogenous re infusion (HFR) for cases 2

Intervention Type PROCEDURE

Other Intervention Names

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medical treatment Measurement of C1q levels

Eligibility Criteria

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Inclusion Criteria

* systemic lupus erythematosus in activity

Exclusion Criteria

* End stage renal disease, other renal replacement therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Mohamed Ahmed El ghiriani

OTHER

Sponsor Role lead

Responsible Party

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Dr. Mohamed Ahmed El ghiriani

PhD student, Faculty of medicine, Alexandria university, Egypt

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Naga S Salah, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

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Faculty of Medicine Alexandria University

Alexandria, Sidi Beshr, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PhD MElghiriani

Identifier Type: -

Identifier Source: org_study_id

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