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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | hemodiafiltration 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.