rine Interferon Inducible Protein-10 Guided Treatment to Reduce Lupus Nephritis Flares

Phase 4

Active, not recruiting

• Conditions: Systemic lupus erythemoatosus Lupus nephritis; Systemic lupus erythemoatosus; Lupus nephritis; Urine interferon inducible protein-10; Preemptive immunosuppressive treatment

• Registration Number: TCTR20190517004
• Lead Sponsor: ational Science and Technology Development Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-17
• Study Completion: 2024-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

1.Age 18-65 years
2.Diagnosis of SLE according to American College of Rheumatology (ACR) 1997 or The Systemic Lupus International Collaborating Clinics (SLICC) criteria
3.History of lupus nephritis, either clinical diagnosis or biopsy proven lupus nephritis class III, IV or V who completed at least 3-month course of induction therapy
4.Achieved remission within 12 months from the initiation of induction therapy, defined by more than 50% reduction of proteinuria from baseline and the level less than 3 g/g or g/day
5.Urinary protein level < 3 g/g or g/day in the past 6 months
6.Immunosuppressive medications were not increased for at least 3 months.

Exclusion Criteria

1.Clinical renal flare in the past 6 months defined by:
1.1Equal or more than 25% increase of creatinine for at least 2 consecutive times in the past 6 months without other contributing factors and/or
1.2If baseline uPCR is:
1.2.1 Equal or less than 500 mg/g, an increase to more than 1000 mg/g for at least 2 consecutive times in the past 6 months without other contributing factors
1.2.2 More than 500 mg/g, an increase of equal or more than 2-fold for at least 2 consecutive times in the past 6 months without other contributing factors
2.Severe extra-renal involvement of SLE
3.Receipt of prednisolone more than 7.5 mg/day
4.Receipt of mycophenolate mofetil(MMF) more than 1.5 g/day
5.Receipt of azathioprine more than 2 mg/kg/day
6.Receipt of methotrexate more than15 mg/week
7.Receipt of calcineurin-inhibitor
8.Receipt of leflunomide
9.Treatment with cyclophosphamide within the past 6 months
10.Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time within 12 months
11.Estimated-GFR less than 30 mL/min/1.73 m2
12.Pregnancy or breast feeding
13.Poor compliance
14.Known active, clinically significant infection of any kind
15.History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
16.Poorly controlled diabetes mellitus (HbA1c > 8% in the past 6 months)
17.Uncontrolled concomitant disease
18.Contraindications for treatment with corticosteroids, such as a history of steroid induced psychosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified