NCT01288664WithdrawnPhase 3
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis
Sun Yat-sen University1 site in 1 countryStarted: January 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Remission rate (complete or partial remission)
Study Overview
Brief Summary
This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects of either sex, 14-65 years of age;
- •Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
- •Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V;
- •LN (Class IV+V): proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), > 5 red blood cell count (RBC)/hpf;
- •LN (Class V or III +V ): proteinuria > 2g/24hr or Scr > 1.3 mg/dl;
- •Provision of written informed consent by subject or guardian
Exclusion Criteria
- •Inability or unwillingness to provide written informed consent
- •Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment
- •Scr > 4mg/dl (354umol/L)
- •Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
- •Lupus encephalopathy
- •Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma)
- •History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
- •Any Active systemic infection or history of serious infection within one month of entry
- •known infection with HIV, hepatitis B, or hepatitis C
- •Known hypersensitivity or contraindication to tacrolimus, corticosteroids
- •Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
- •Pregnancy, nursing or use of a non-reliable method of contraception.
Arms & Interventions
ADVAGRAF
Experimental
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months
Intervention: ADVAGRAF (Drug)
Outcomes
Primary Outcomes
Remission rate (complete or partial remission)
Time Frame: 6 months
Secondary Outcomes
- relapse(every 3 months, up to 6 months)
- renal function(every 3 months, up to 6 months)
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores(every 3 months, up to 6 months)
- Number of participants with adverse events as a measure of safety and tolerability(every 3 months, up to 6 months)
- proteinuria(every 3 months,up to 6 months)
Investigators
Study Sites (1)
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