Clinical trial NCT01328834: Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nephritis, Lupus
Keywords: Nephritis, Lupus
Tacrolimus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 20
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 a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).


Eligibility criteria: Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
2. Diagnosis of SLE according to the ACR criteria (1997);
3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
4. Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
5. proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 WBC/high power field (hpf) (excluding infection), \> 5 RBC/hpf);
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, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
3. Scr \> 4mg/dl (354umol/L);
4. Needing pulse intravenous MP or intravenous immunoglobulin;
5. Lupus encephalopathy;
6. Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
7. History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
8. Known hypersensitivity or contraindication to tacrolimus, corticosteroids
9. Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;
11. Pregnancy, nursing or use of a non-reliable method of contraception.

Primary outcomes:
measure: Remission rate (complete or partial remission)
timeFrame: 6 months after therapy
Secondary outcomes:
measure: The changes of proteinuria
timeFrame: every 3 months up to 6 months
measure: 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: The changes of 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 IRB
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Yu Xueqing, MD
role: PRINCIPAL_INVESTIGATOR
References: