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Status unknownNCT04756492Updated Feb 16, 2021

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

An observational study in We Aim to Examine the Predictors of Sustained Complete Renal Remission in Patients With Lupus Nephritis at Sohag University Hospital, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
14 Years to 60 Years
Sex
All
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Study summary

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

Read the detailed description

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

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Conditions studied

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

Nephritis

245 studies on the registry are indexed under Nephritis; 56 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 69 observational studies indexed under Nephritis.

Browse Nephritis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

o Patients diagnosed with LN at Sohag University Hospital

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Drugsandimmun

    follow up for treatment response

    Also known as: indoxan

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What researchers measure

Primary outcomes

  1. complete renal response

    Alb _35 g/l, UPCR\<0.3 g/g, a normal range of sCr or at a level increasing no more than 15% from baseline and without lupus flares.

    Time frame: 6 months

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Study locations

1 site
  • Sohag University
    Sohag, 088, Egypt
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References and documents

Individual participant data

Plan to share: No — sharing final results only

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04756492
Lead sponsor
Sohag University
Responsible party
Ahmed Mahmoud Helmy (assistant lecture, Sohag University) — Principal investigator
First posted
Feb 16, 2021
Start date
Feb 15, 2021
Primary completion
Feb 15, 2023 (estimated)
Completion
Feb 15, 2023 (estimated)
Last update
Feb 16, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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