NCT06588192

Brief Summary

Systemic lupus erythematous is a chronic multifactorial autoimmune disease that affects many organs including kidney. Lupus nephritis is a common manifestation characterized by heterogeneous clinical and histopathological finding and often associate with poor progression and despite potent anti-inflammatory and immunosuppressive therapies still end in CKD or ESRD for too many patient. lupus nephritis is an immune complex GN that develop as a frequent complication of SLE. The pathogenesis of lupus nephritis involve a variety of pathogenic mechanisms, intra renal pathomechanisn of SLE related nephritis immune complex formation and classical complement pathway activation. Lupus nephritis doesn\'t develop in the absence of antinuclear antibodies. Circulating polyclonal autoantibodies bind to intrarenal nucleosomes and other autoantigen, which lead to local complement activation , cell injury and subsequent cytokine and chemokine secretion . The current management of lupus nephritis remain based on steroids, cyclophosphamide, azathioprine ,mycophenolate mefetile which are all unselective immunosuppressive drugs, these drugs have proven to be efficient in reducing lupus nephritis disease activity but the long term outcomes of lupus nephritis have not further improved during the last 30 years . Identification of renal survival is mandatory for certain purposes i.e, evaluation of efficacy of different treatment strategies among our patients and factors associated with the survival data as compared with other specialized centers.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Oct 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Oct 2024Mar 2027

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

September 5, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

lupusnephritis

Outcome Measures

Primary Outcomes (1)

  • Assessment of two and five years renal survival among patients with lupus nephritis

    2-5 years observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

nephrology department, Assiut University Hospital inpatient and outpatient clinics

You may qualify if:

  • Age\>18years old
  • Patients with SLE as defined by EULAR/ACR criteria and lupus nephritis classification according to ISN/RPS classification.
  • Available medical records for 2 and 5 years of follow up after diagnosis of lupus nephritis

You may not qualify if:

  • Transplant recipients
  • Pregnant females
  • Patients with combined renal pathology other than LN.
  • Those who had no baseline information in hospital medical records and had a follow up duration \< 24 months will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Mahajan A, Amelio J, Gairy K, Kaur G, Levy RA, Roth D, Bass D. Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression. Lupus. 2020 Aug;29(9):1011-1020. doi: 10.1177/0961203320932219. Epub 2020 Jun 22.

    PMID: 32571142BACKGROUND
  • Aringer M. EULAR/ACR classification criteria for SLE. Semin Arthritis Rheum. 2019 Dec;49(3S):S14-S17. doi: 10.1016/j.semarthrit.2019.09.009.

    PMID: 31779843BACKGROUND
  • Yu C, Li P, Dang X, Zhang X, Mao Y, Chen X. Lupus nephritis: new progress in diagnosis and treatment. J Autoimmun. 2022 Oct;132:102871. doi: 10.1016/j.jaut.2022.102871. Epub 2022 Aug 20.

    PMID: 35999111BACKGROUND
  • Liu Y, Anders HJ. Lupus nephritis: from pathogenesis to targets for biologic treatment. Nephron Clin Pract. 2014;128(3-4):224-31. doi: 10.1159/000368581. Epub 2014 Nov 8.

    PMID: 25401461BACKGROUND

MeSH Terms

Conditions

Lupus NephritisNephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Gehad Gehad soudy Ahmed hmad

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

September 19, 2024

Record last verified: 2024-09