TCTR20181002001
Recruiting
Phase 3
Serum Uromodulin †A Potential Biomarker to Predict Response to Lupus Nephritis Treatment in Adults
Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University0 sites43 target enrollmentOctober 2, 2018
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Active lupus nephritis
- Sponsor
- Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
- Enrollment
- 43
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.
Outcomes
Primary Outcomes
Not specified
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