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Serum Uromodulin †A Potential Biomarker to Predict Response to Lupus Nephritis Treatment in Adults

Phase 3
Recruiting
Conditions
Active lupus nephritis
Serum uromodulin
Lupus nephritis
Biomarker
Remission
Registration Number
TCTR20181002001
Lead Sponsor
Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
43
Inclusion Criteria

1. Age of 18 or older
2. Diagnosed systemic lupus erythematosus (SLE) according to 1997 American College of Rheumatology (ACR) criteria
3. Patients with active lupus nephritis requiring induction therapy according to physician opinion. However, kidney biopsy to confirm lupus nephritis is not required. Active lupus nephritis is defined as one of the following:
3.1 Presence of urine protein of more than 0.5 gram per day and presence of red blood cells (RBC) in urine of more than 5 cells per high power field or presence of RBC cast or
3.2 Presence of urine protein of more than 3.0 gram per day if RBC in the urine less than 5 cells per high power field and no RBC cast
3.3 If kidney biopsy was done, presence of the evidence of active lupus nephritis class III, IV or V according to the 2003 International Society for Nephrology/Renal Pathology Society (ISN/RPS) classification criteria

Exclusion Criteria

1. Pregnancy
2. Patients with antiphospholipid syndrome (APS)
3. Patients with thrombotic thrombocytopenic purpura (TTP)
4. Patients with overlapping syndrome
5. Patients who have estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical response to induction therapy Six months after induction therapy Serum creatinine, urine protein, and urine analysis
Secondary Outcome Measures
NameTimeMethod
/A N/A N/A
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