Clinical trial NCT01288664: Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis
Tacrolimus
Induction Phase
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
2. Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
3. 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;
4. 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;
5. LN (Class V or III +V ): proteinuria \> 2g/24hr or Scr \> 1.3 mg/dl;
6. Provision of written informed consent by subject or guardian

Exclusion Criteria:

1. Inability or unwillingness to provide written informed consent
2. 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
3. Scr \> 4mg/dl (354umol/L)
4. Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
5. Lupus encephalopathy
6. Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma)
7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
8. Any Active systemic infection or history of serious infection within one month of entry
9. known infection with HIV, hepatitis B, or hepatitis C
10. Known hypersensitivity or contraindication to tacrolimus, corticosteroids
11. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
12. Pregnancy, nursing or use of a non-reliable method of contraception.

Primary outcomes:
measure: Remission rate (complete or partial remission)
timeFrame: 6 months
Secondary outcomes:
measure: proteinuria
timeFrame: every 3 months,up to 6 months
measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores
timeFrame: every 3 months, up to 6 months
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: every 3 months, up to 6 months
measure: renal function
timeFrame: every 3 months, up to 6 months
measure: relapse
timeFrame: every 3 months, up to 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Yu Xueqing, MD
role: PRINCIPAL_INVESTIGATOR
References: