Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital

NCT ID: NCT04756492

Last Updated: 2021-02-16

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2023-02-15

Brief Summary

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Systemic lupus erythematosus (SLE) is an autoimmune disease which may give rise to multiple organ involvement because of immune complex deposits. Lupus nephritis (LN) is one of the severe manifestations of systemic lupus erythematous (SLE) and a common cause for end-stage renal disease, significantly affecting the survival of SLE patients Immunosuppressive treatment is the major therapy for active LN. Generally, at least six months are needed to assess treatment responses Failure to respond to immunosuppressive therapy can lead to a worsening of renal function

Detailed Description

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This study will be prospectively analyzing the clinical data of LN patients who received standard immunosuppressive therapy and were regularly followed up at our center for more than six months. These patients will not change treatment regimen during the six months.

As remission is an independent predictor of good long term prognosis in lupus nephritis. We aim to examine the predictors of sustained complete renal remission in patients with lupus nephritis at Sohag University Hospital and to analyze data of lupus nephritis patients to find parameters that can predict remission and improve outcome of our cases

Conditions

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We Aim to Examine the Predictors of Sustained Complete Renal Remission in Patients With Lupus Nephritis at Sohag University Hospital

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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sandimmun

follow up for treatment response

Intervention Type DRUG

Other Intervention Names

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indoxan

Eligibility Criteria

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Inclusion Criteria

* o Patients diagnosed with LN at Sohag University Hospital

* Patients in regular follow-up for more than six months after immunosuppressive therapy
* Baseline urinary protein/creatinine ratio (UPCR) more than 1 g/g
* Baseline C3 less than 55 mg/ dl
* No change in immunosuppressive therapy within six months

Exclusion Criteria

* o Patients with incomplete pathological data and the number of glomeruli being \<10 per biopsy specimen

* Age \<14 years old End-stage renal disease (ESRD) status on admission (sustained estimated glomerular filtration rate (eGFR) \<15 ml/min per 1.73m2)
* Patients with advanced comorbid conditions like advanced liver cirrhosis or heart failure or malignancy
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahmoud Helmy

assistant lecture

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-21-02-06

Identifier Type: -

Identifier Source: org_study_id

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