Immune Adsorption Role in Treatment of Resistant Lupus

NCT04108611 | Completed DMC

• 1 other identifier: PhD MElghiriani
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Lupus

Keywords

hemodiafiltration with endogenous re infusion; immune adsorption In Lupus nephritis

Outcome Measures

Primary Outcomes (1)

• Improvement In signs and symptoms of lupus activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

  For cases group

  12 months

Study Arms (2)

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

Procedure: hemodiafiltration with endogenous re infusion (HFR)

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

Procedure: hemodiafiltration with endogenous re infusion (HFR)

Interventions

hemodiafiltration with endogenous re infusion (HFR) PROCEDURE

hemodiafiltration with endogenous re infusion (HFR) for cases 2

Also known as: medical treatment, Measurement of C1q levels

Control group 30 subjects; systemic lupus in activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• systemic lupus erythematosus in activity

You may not qualify if:

• End stage renal disease, other renal replacement therapy

Sponsors & Collaborators

• Dr. Mohamed Ahmed El ghiriani: lead

Study Sites (1)

Faculty of Medicine Alexandria University

Alexandria, Sidi Beshr, 21624, Egypt

Location

MeSH Terms

Interventions

Hemodiafiltration

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Naga S Salah, Professor

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Patients will not be masked as hemodiafiltration with endogenous re infusion must be observed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student, Faculty of medicine, Alexandria university, Egypt

Model Details: Role of online hemodiafiltration with endogenous re infusion in treatment of systemic lupus erythematosus activity resistant to conventional therapy

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: January 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: September 25, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 days, forever available
• Access Criteria: no specific criteria

Locations

EG (1)