Systemic lupus erythemoatosus Lupus nephritis Systemic lupus erythemoatosus Lupus nephritis Urine interferon inducible protein-10 Preemptive immunosuppressive treatment
Conditions
Interventions
- Prednisolone will be increased to 20 mg/day and tapered by 5 mg/day every week until 5 mg/day is reached.
In addition to prednisolone, the dose of maintenance immunosuppressive medication will be a
Experimental Drug,Placebo Comparator No treatment
Preemptive immunosuppressive treatment group,Standard of care group
Sponsors
National Science and Technology Development Agency
Health System Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
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
Exclusion criteria: 1. Clinical renal flare in the past 6 months defined by: 1.1 Equal or more than 25% increase of creatinine for at least 2 consecutive times in the past 6 months without other contributing factors and/or 1.2 If 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lupus nephritis flare 12 months Renal biopsy, serum creatinine, urinary protein creatinine index | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe renal flare requiring plasmapheresis, IVIG or renal replacement therapy 12 months Number of events,Cumulative dose of immunosuppression 12 months prednisolone dosage(mg),Adverse events 12 months number of events,Number of renal biopsy procedure 12 months number of events,Non-renal SLE flare 12 months number of events,Quality of life 12 months EQ-5D-5L,Healthcare related cost 12 months Baht | — |
Countries
Thailand
Contacts
Public ContactWonngarm Kittanamongkolchai
Chulalongkorn University
Outcome results
None listed