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

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

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04756492
• Other study ID #: Soh-Med-21-02-06
• Status: Active, not recruiting
• Start date: February 15, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• sandimmun
follow up for treatment response

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months