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

NCT04756492 | Unknown DMC

• 1 other identifier: Soh-Med-21-02-06
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

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.

  6 months

Interventions

sandimmun DRUG

follow up for treatment response

Also known as: indoxan

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

o Patients diagnosed with LN at Sohag University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 088, Egypt

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 16, 2021
• Study Start: February 15, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)